Clinical Trials and Prospective Studies
A rundown of the latest clinical trials and prospective studies now enrolling patients at the Heart Center.
Title: Intravenous Remodulin (Treprostinil) as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Randomized, Placebo-Controlled, Safety and Efficacy Study
Description: This study investigates whether the addition of IV Remodulin will reduce the rate of clinical worsening as compared to standard of care in PPHN subjects who do not show an adequate response to iNO. Additionally, the study will evaluate the safety and treatment effects of IV Remodulin in the neonatal population.
Enrollment goal: 1-4 subjects
Primary investigator: Mary Mullen MD, PhD
Contact: Alessandra Russo: Alessandra.Russo@cardio.chboston.org or 857-218-3847
Title: Investigation of Actigraphy, an Exercise Measurement Device, as a Novel, Well-Defined, Reliable, Feasible, Easy to Use, and Non-Invasive Study Endpoint to Facilitate Pediatric Pulmonary Arterial Hypertension Trials and Drug Development
Description: This prospective, multi-center study investigates the utility of actigraphy as a clinical measure of physical activity in children with PAH. More specifically, the study will focus on describing the use of actigraphy in children and determining if correlations exist between actigraphy data and disease severity, progression, clinical worsening, and survival in children with PAH.
Enrollment goal: 10-15 subjects
Primary investigator: Mary Mullen MD, PhD
Contact: Alessandra Russo: Alessandra.Russo@cardio.chboston.org or 857-218-3847
Title: TOMORROW: Pediatric Use of Macitentan to Delay Disease Progression in PAH Worldwide
Description: The purpose of this study is to evaluate macitentan in comparison to standard of care (SoC) with regard to delaying disease progression in children with PAH. In addition, this study aims to assess the safety, tolerability, and pharmacokinetics of macitentan in children ages 2-17 with PAH.
Enrollment goal: 2-4 subjects
Primary investigator: Mary Mullen MD, PhD
Contact: Alessandra Russo: Alessandra.Russo@cardio.chboston.org or 857-218-3847
Title: Open-label, individual dose titration study to evaluate safety, tolerability, and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH)
Description: The open-label, individual dose titration study aims to evaluate the safety, tolerability and pharmacokinetics of oral riociguat treatment in children (ages 6-18) with pulmonary arterial hypertension (PAH). The study will also explore the efficacy of the drug in this pediatric population.
Enrollment goal: 2-4 subjects
Primary investigator: Mary Mullen MD, PhD
Contact: Alessandra Russo: Alessandra.Russo@cardio.chboston.org or 857-218-3847
Title: CAscade SCreening for Awareness and DEtection of Familial Hypercholesterolemia (CASCADE) Registry
Description: The purpose of this project is to add a regional supplement to a registry collecting and maintaining de-identified clinical information about patients with familial hypercholesterolemia (FH). The information will be used to track trends in therapy, events and outcomes in individuals diagnosed with FH. This information will further provider knowledge and understanding of the disease, and improve the care, quality of life and survival of those with FH.
Enrollment goal: 5,000 diagnosed individuals nationwide
Primary investigator: Sarah D. de Ferranti, MD, MPH
Contact: Heather Harker Ryan, MS, RN: heather.harker@cardio.chboston.org or (617) 355-0955
Title: GORE CARDIOFORM ASD Occluder Clinical Study: A study to evaluate safety and efficacy in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs) – The Gore ASSURED Clinical Study
Description: The goal of this study is to evaluate the safety and efficacy of a new ASD occluder device as part of an FDA-approved IDE multicenter trial.
Enrollment goal: 20 subjects
Primary investigator: Lisa Bergersen, MD, MPH
Contact: Cardio Outcomes Clinical Research Staff: CardioOutcomes@childrens.harvard.edu or 617-355-8228
Title: New Enrollment SAPIEN XT Post-Approval Study (COMPASSION XT PAS)
Description: The goal of this study is to evaluate the safety of the FDA-approved SAPIEN XT THV in the pulmonic position.
Enrollment goal: 28 subjects
Primary investigator: Diego Porras, MD
Contact: Cardio Outcomes Clinical Research Staff: CardioOutcomes@childrens.harvard.edu or 617-355-8228
Title: Neurocognitive function of adolescents and young adults with repaired complex congenital heart disease after recent cardiac re-interventions: a pilot study
Description: The goal of this study is to determine the impact of right ventricular outflow tract re-intervention on neurocognitive function for patients with repaired complex congenital heart disease who are scheduled surgical or transcatheter pulmonary valve replacement.
Enrollment goal: 20 subjects
Primary investigator: Lisa Bergersen, MD, MPH
Contact: Cardio Outcomes Clinical Research Staff: CardioOutcomes@childrens.harvard.edu or 617-355-8228
Title: Anatomic and Hemo-dynamic results of the Cone operation for Ebstein’s malformation of the tricuspid valve
Description: The cone operation is a procedure to repair the tricuspid valve in patients with Ebstein’s anomaly using the patient’s own tissue. Short-term results have shown that the cone repair has improved valvar function as compared to conventional tricuspid valve type repair. The purpose of this study is to determine long-term results of tricuspid valve function, right ventricular remodeling and quality of life at our institution with noninvasive imaging, exercise testing and a quality of life questionnaire.
Enrollment goal: 130 subjects
Primary investigator: Gerald Marx, MD
Contact: Mariana Chávez, MD: Mariana.Chavez@childrens.harvard.edu or 617-355-3515
Title: Utilization of Confocal Microscopy during Cardiac Surgery
Description: This is a pilot study, exploring the safety and feasibility of using dilute fluorescein sodium with fiberoptic confocal microscopy in patients undergoing surgical atrial septal defect closure. The primary aim is to evaluate the safety of using diluted fluorescein sodium during cardiac surgery. The secondary aim is to evaluate the feasibility of using this imaging modality to identify conduction tissue in the heart.
Enrollment goal: 6 subjects
Primary investigator: Aditya Kaza, MD
Contact: Bre Piekarski: Breanna.Piekarski@cardio.chboston.org or 617-919-4457; Leah Cheng: leah.cheng@childrens.harvard.edu or 857-218-4731
Title: Boston Circulatory Arrest Study- Adult: Antecedents and Correlates of Well-Being in Adults with Transposition of the Great Arteries
Description: This study evaluates long-term neuropsychological, mental health and well-being outcomes in adults with d-loop transposition of the great arteries who were enrolled as part of the initial BCAS cohort from 1988-1992. Study participants will complete full neuropsychological and mental health evaluations as well as a brain MRI.
Enrollment goal: 100 subjects (out of an original cohort of 171) and 50 controls
Primary investigator: Michelle Gurvitz, MD, MS
Contact: Donna Duva: donna.duva@cardio.chboston.org or 617-355-5422
Title: Phase III Multi-Center Open Label Randomized Clinical Trial Comparing Everolimus and Low Dose Tacrolimus to Tacrolimus and Mycophenolate Mofetil at 6 Months Post Heart Transplant to Prevent Long-Term Complications after Pediatric Heart Transplantation
Description: This study is a randomized trial with children who have undergone recent heart transplant, to determine whether a new rejection treatment (everolimus and low-dose tacrolimus) can reduce or prevent complications of transplant, including rejection, coronary artery disease and kidney disease, when compared to usual care (tacrolimus and mycophenolate mofetil).
Enrollment goal: 14 subjects
Primary Investigator: Kevin P. Daly, MD
Contact: Matthew MacLean: Matthew.MacLean@cardio.chboston.org or 617-355-4213
Title: The National Pediatric Cardiology Quality Improvement Collaborative- A Collaborative Initiative to Improve the Care of Children with Complex Congenital Heart Disease- Phase II
Description: The National Pediatric Cardiology Quality Improvement Collaborative is a research and quality improvement network whose mission is to improve the outcomes of care for children with single ventricle congenital heart disease. Parent’s consent to enrollment in a Registry Database and statistical analysis informs Quality Improvement Efforts and Outcome Assessment.
Enrollment Goal: Open enrollment for the next 3-5 years
Primary investigator: David Brown, MD
Primary Contact: Terry Saia, PNP: terry.saia@cardio.chboston.org or 617-355-8437
Title: Living with Congenital Aortic Stenosis: Exercise Restriction, Patterns of Adherence, and Quality of Life
Description: Prospective study of patients with congenital aortic stenosis and their cardiologists using brief survey instruments including validated quality of life assessment.
Enrollment Goal: 100 patient/physician pairs, including participating NECCA sites
Primary Investigators: Laura Mansfield, MD, and David Brown, MD
Contact: Laura Mansfield, MD: Laura.Mansfield@cardio.chboston.org or 978-501-6176
Title: Apixaban vs. VKA or LMWH in Pediatric Subjects with Congenital or Acquired Heart Disease on Chronic Anticoagulation for Thromboembolism Prevention
Description: This is a multi-center, randomized trial designed to assess the safety and pharmacokinetics of the anticoagulation agent Apixaban compared to conventional anticoagulation drugs in children with acquired and congenital heart disease. At Boston Children’s Hospital, up to 40 children between 2 to < 18 years of age will be enrolled and receive therapy for up to 12 months.
Enrollment goal: 40 subjects
Primary investigator: Christina VanderPluym, MD
Contact: Najveen Alvi: Najveen.Alvi@cardio.chboston.org or 617-355-7245
Title: Long-Term Outcomes of Children with Hypoplastic Left Heart Syndrome (HLHS) and the Impact of Norwood Shunt Type Study (SVR III)
Description: The purpose of this study is to determine which type of shunt placed at the time of the Norwood operation is most effective by school age. Specifically, long-term differences in heart function, exercise tolerance, neurodevelopment or quality of life will be explored. Participants will undergo cardiac MRI, echocardiogram, exercise testing and neurodevelopmental testing.
Enrollment goal: 30 subjects
Primary investigator: Jane W. Newburger, MD, MPH
Contact: Carolyn Dunbar-Masterson, RN: Carolyn.Dunbar-Masterson@cardio.chboston.org or 617-355-4201
Title: Single Ventricle Reconstruction Study III: Brain Connectome and Neurodevelopmental Outcomes (Healthy Controls)
Description: The purpose of this study is to compare the brain structures and long-term development in individuals who have been diagnosed with CHD with those who were born healthy and have not been diagnosed with CHD. Participants will undergo a brain MRI and neurodevelopmental testing.
Enrollment: 30 healthy controls
Primary Investigator: Jane W. Newburger, MD, MPH
Contact: Carolyn Dunbar-Masterson, RN: Carolyn.Dunbar-Masterson@cardio.chboston.org or 617-355-4201
Title: Pharmacodynamics, Pharmacokinetics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan
Description: This prospective, open label, active-controlled, multicenter study is tasked with the goal to evaluate the safety and optimal dosing of rivaroxaban (an oral anticoagulation agent) compared to acetylsalicylic acid for thrombus prevention in children aged 2 to 8 years with single ventricle physiology who have completed the Fontan procedure. Participants will receive therapy for up to 12 months.
Enrollment goal: 25 subjects
Primary investigator: Christina VanderPluym, MD
Contact: Priscilla Cevallos: Priscila.Cevallos@cardio.chboston.org
Title: Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects under General Anesthesia
Description: A prospective, randomized, controlled trial to determine the utility of functional near infrared spectroscopy (fNIRS) in the objective, quantitative assessment of nociception and anti-nociception (analgesia) in patients under general anesthesia.
Enrollment goal: 54 subjects
Primary investigator: Barry D. Kussman, MBBCh, FFA(SA)
Contact: Rachel Bernier, MPH: rachel.bernier@childrens.harvard.edu or 857-218-5348
Title: PumpKIN (Pump for Kids, Infants and Neonates) Safety and Efficacy of Jarvik VAD for Children Sized 8 to 20 kg
Description: This multicenter, two-arm clinical trial will evaluate the safety and potential benefit of the Jarvik 2015 versus the EXCOR Pediatric as a bridge to transplant in smaller children with severe heart failure.
Enrollment goal: 15 subjects
Primary investigators: Christina VanderPluym, MD, and Francis Fynn-Thompson, MD
Contact: Christina VanderPluym, MD: Christina.vanderpluym@cardio.chboston.org
Title: Levosimendan Expanded Access Compassionate Use in Pediatric Patients with Advanced Decompensated Heart Failure who are Refractory to Standard Therapy
Description: To obtain clinical access to levosimendan, a calcium-sensitizing inodilator, for pediatric patients under FDA expanded access to infants and children in severe decompensated heart failure who are not responding to standard care.
Enrollment goal: 80 subjects
Primary investigators: Peta Alexander, MBBS
Contact: Peta Alexander, MBBS: Peta.alexander@cardio.chboston.org or 617-355-7866
Title: Parent-Physician Communication, Prognostic Awareness and Symptom Burden in Children with Advanced Heart Disease
Description: This study prospectively evaluates quality of life, parent understanding of prognosis and goals of care, and parent-caregiver communication related to the care of children with advanced heart disease. Parent, physician and bedside nurse enrollment will occur simultaneously.
Enrollment goal: 20-patient pilot, followed by 160 parent/physician/nurse triads
Primary investigator: Betsy Blume, MD
Contact: Rocky Reichman: Jeffrey.Reichman@cardio.chboston.org
Title: Pharmacodynamics, Pharmacokinetics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan
Description: This prospective, open label, active-controlled, multicenter study is tasked with the goal to evaluate the safety and optimal dosing of rivaroxaban (an oral anticoagulation agent) compared to acetylsalicylic acid for thrombus prevention in children aged 2 to 8 years with single ventricle physiology who have completed the Fontan procedure. Participants will receive therapy for up to 12 months.
Enrollment goal: 10 subjects
Primary investigator: Christina VanderPluym, MD
Contact: Rocky Reichman: Jeffrey.Reichman@cardio.chboston.org
Title: Evaluation of the safety and tolerability of oral ENTRESTO for the treatment of pediatric heart failure patients
Description: Multicenter, dose-escalation study to define the pharmacokinetics, pharmacodynamics, safety and tolerability of ENTRESTO (valsartan/sacubitril) in pediatric patients with heart failure. Patients less than 18 years of age with two ventricle heart disease and systolic heart failure (LVEF<40%) are eligible to participate.
Enrollment Goal: 3 subjects
Primary Investigator: Kevin P. Daly, MD
Contact: Kevin Daly, MD: kevin.daly@cardio.chboston.org; Jane Messere, BSN RN: jane.messere@cardio.chboston.org or 857-719-6391
Title: A multicenter, randomized controlled trial comparing standard of care enalapril to ENTRESTO for the treatment of pediatric heart failure
Description: This is a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of ENTRESTO (valsartan/sacubitril) compared with enalapril in pediatric heart failure patients. Patients must be less than 18 years of age with two ventricle heart disease and systolic heart failure (LVEF < 40%) to be eligible to enroll.
Enrollment Goal: 18 subjects
Primary Investigator: Kevin P. Daly, MD
Contact: Kevin Daly, MD: kevin.daly@cardio.chboston.org; Jane Messere, BSN RN: jane.messere@cardio.chboston.org or 857-719-6391
Title: A Prospective Adult Congenital Heart Disease Biorepository
Description: This study involves prospectively collecting and storing blood and urine specimens for adults who have congenital heart disease. The ultimate aim is to facilitate research into underlying mechanisms of deterioration and development of diagnostic tools to better predict the incidence of specific adverse outcomes.
Enrollment Goal: Ongoing
Primary Investigator: Alexander Opotowsky, MD, MPH
Contact: Catherine Gray, BS: Catherine.gray@cardio.chboston.org or 617-919-4458
Title: Prospective, Non‐randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Description: The Edwards Pericardial Bioprosthesis, Model 11000A, is indicated for patients 5 years or older requiring replacement of their native or prosthetic pulmonary valve. The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Bioprosthesis Model 11000A in the pulmonary position. This is a prospective, non-randomized, single arm, multicenter study. Up to 100 pulmonary valve replacement (PVR) subjects at up to 10 clinical sites will be enrolled. Clinical data will be collected from patients enrolled for 5 years after the 100th patient is enrolled. Data will be collected from at least three centers with data available on a minimum of 15 patients who have completed the one-year follow-up visit.
Enrollment goal: 30-50 subjects per site
Primary investigator: Christopher W. Baird, MD
Contact: Michele J Borisuk, MSN, CPNP: Michele.borisuk@cardio.chboston.org or 617-355-3515
Title: Prospective, non-randomized, open label clinical study to assess the feasibility of the Bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction
Description: The Bioabsorbable pulmonary valved (PV) conduit is a gamma sterilized, bioabsorbable, polymer-based medical device. The valve itself is formed by three leaflets, which are incorporated within the conduit wall. This is a prospective, multicenter, non-randomized, single arm, open label, clinical study. The Bioabsorbable pulmonary valved conduit is used for the reconstruction of the right ventricular outflow tract (RVOT). There is no specific device-related surgical procedure necessary for the implantation. Pulmonary valve replacement is the only treatment proven to reduce right ventricular size and improve right ventricular function in the long term. The PV conduit is used for correction or reconstruction of the right ventricular outflow tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations: tetralogy of Fallot, truncus arteriosus, pulmonary atresia, transposition of great arteries with ventricular septal defect, pulmonary stenosis in combination with other defects in congenital heart defect (CHD) syndromes. In addition, the PV conduit can be used for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits. The PV conduit is surgically implanted using the same surgical technique as would be used for any standard homograft or off-the-shelf PV conduit. No special medication is required other than standard practice. The patient will be followed and data collected to evaluate the growth of the conduit at 6, 36, 48 and 60 months in pediatric population under 18 years.
Enrollment goal: 2-3 subjects per site. Total trial goal enrollment is 10.
Primary investigator: Christopher W. Baird, MD
Contact: Michele J Borisuk, MSN, CPNP: Michele.borisuk@cardio.chboston.org or 617-355-3515
Title: HALO Clinical Study: A single arm, prospective, non-randomized, multi-center clinical investigation of the SJMTM Masters HP 15mm Rotatable Mechanical Heart Valve
Description: With the current commercially-available mechanical mitral valves size ranges of 16mm to 37mm and the mitral annulus in young pediatric patients ranging from 12mm to 30mm with a mean of 18mm and evidence existing that suggests oversized valves are associated with increased mortality and morbidity rates, particularly in the very young patient population, a 15mm investigational mechanical heart valve (MHV) is being studied. A mitral valve annulus will typically require a sewing diameter of approximately 2mm larger than the valve size. As a 16mm valve is currently the smallest diameter valve on the market, there is a portion of the pediatric population that would benefit from the availability of a smaller diameter valve. This is made possible by removing the sewing cuff from the annulus. The investigational device is a 15mm, rotatable, bi-leaflet MHV designed for implantation in the mitral position. This valve is part of the SJMTM Masters HP Series product line. The study is a single arm, prospective, non-randomized, multicenter clinical investigation. Each enrolled subject will be assessed at baseline, procedure, post- procedure, 30 days, six months, 12 months and annually thereafter for as long as the valve remains implanted, but not to exceed five years.
Enrollment goal: 2-3 subjects per site. Total trial goal enrollment is 20.
Primary investigator: Christopher W. Baird, MD
Contact: Michele J Borisuk, MSN, CPNP: Michele.borisuk@cardio.chboston.org or 617-355-3515
Title: Data Fusion: A Sustainable, Scalable, Open Source Registry Advancing PVD Research
Description: We are recruiting patients diagnosed with pediatric pulmonary hypertension (PH) before the age of 18. No additional visits or tests will be conducted and all information will be de-identified. Data will be compared to others to learn more about treatment and improve care for patients.
Enrollment Goal: 1200+ subjects
Primary investigator: Mary Mullen MD, PhD
Contact: Jessica Mecklosky: Jessica.Mecklosky@cardio.chboston.org or 617-919-4456
Title: Placenta Biopsies in Hypoplastic Left Heart Syndrome Patients
Description: Placental biopsies will be collected from women with fetuses diagnosed with hypoplastic left heart syndrome (HLHS) at the time of delivery. The goal is to compare the growth of stem cells from a placenta of a child with HLHS to cells from neonates with no known medical diagnosis.
Enrollment goal: 10 subjects
Primary investigator: Sitaram Emani, MD
Contact: Bre Piekarski, RN, BSN: Breanna.Piekarski@cardio.chboston.org or 617-919-4457
Title: Endocardial Fibroelastosis Collection in Cardiac Surgery
Description: We would like to both prospectively and retrospectively collect samples of surgically removed endocardial fibroelastosis (EFE) from cardiac surgery patients and link cellular analysis of the samples to surgical outcomes and cardiac imaging. All EFE will be removed as part of surgical care and would otherwise be discarded. The most up-to-date imaging will be reviewed for each corresponding sample.
Enrollment goal: 20 subjects
Primary investigator: Sitaram Emani, MD
Contact: Bre Piekarski, RN, BSN: Breanna.Piekarski@cardio.chboston.org or 617-919-4457
Title: Surgical Planning with 3-D Printed Cardiac Models in Patients with Malformations that Require Biventricular Repair
Description: It is hypothesized that pre-op surgical planning via inspection of a 3-D printed cardiac model will reduce time spent inspecting the intracardiac anatomy, and thus also reduce OR time, reduce the incidence of residual lesions, and improve comfort and confidence levels of the surgeon.
Enrollment goal: 30 subjects
Primary investigator: Sitaram Emani, MD
Contact: Bre Piekarski, RN, BSN: Breanna.Piekarski@cardio.chboston.org or 617-919-4457
Title: Transplantation of Autologously Derived Mitochondria for Protection against Ischemia-Reperfusion Injury following Ischemia Due to ECMO
Description: A robust therapeutic intervention is proposed to ameliorate myocardial ischemia/reperfusion injury and significantly decrease morbidity and mortality in patients requiring extracorporeal membrane
oxygenation (ECMO), by direct injection of autogeneic mitochondria into the ischemic myocardium.
Enrollment goal: 10 subjects
Primary investigator: Sitaram Emani, MD
Contact: Bre Piekarski, RN, BSN: Breanna.Piekarski@cardio.chboston.org or 617-919-4457
Title: Mesoblast Stem Cell Therapy for Patients with Single Ventricle and Borderline Left Ventricle
Description: This is a randomized trial for those patients with hypoplastic left heart syndrome (HLHS), unbalanced atrioventricular canal (uAVC), or borderline left heart undergoing LV recruitment or future plans
for recruitment. Subjects will receive mesenchymal precursor cells (MPCs) injected directly into the LV endocardium during their planned surgical procedure.
Enrollment goal: 24 subjects
Primary investigator: Sitaram Emani, MD
Contact: Bre Piekarski, RN, BSN: Breanna.Piekarski@cardio.chboston.org or 617-919-4457
Title: Determining the Natural and “Unnatural” History of Anomalous Aortic Origin of a Coronary Artery with an Interarterial Course (AAOCA): Establishing a Multi-Institutional Registry
Description: A risk stratification model will be created utilizing a large, multi-institutional registry under the auspices of the Congenital Heart Surgeon Society (CHSS). The purpose of the study is to determine the outcome of surgical intervention versus observation in children and young adults with AAOCA.
Enrollment goal: 200 subjects
Primary investigator: Meena Nathan, MD
Contact: Bre Piekarski, RN, BSN: Breanna.Piekarski@cardio.chboston.org or 617-919-4457
Title: Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery
Description: This is a safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts/conduits, as well as patches in neonatal cardiac surgery. At time of delivery, the umbilical cord will be
harvested with the umbilical vein dissected free and preserved until first clinically indicated stage I palliative procedure.
Enrollment goal: 16 subjects
Primary investigator: Sitaram Emani, MD
Contact: Bre Piekarski, RN, BSN: Breanna.Piekarski@cardio.chboston.org or 617-919-4457