The Heart House Clinical Research

The Heart House conducts numerous FDA-regulated investigational medical studies with the goal of advancing scientific knowledge, preventing disease, and improving healthcare for all patients. These studies are sponsored by pharmaceutical & device companies as well as government and educational institutions. Clinical research studies are conducted as part of the process of obtaining FDA approval for new medical treatments so that they can be used by the public safely and effectively.

The Heart House has had a dedicated clinical research department since 1996. Today, our clinical research department is the largest in the region. Research studies are conducted at all our office located in Haddon Heights, Elmer, Washington Township and Cherry Hill, as well as at local hospitals. Our commitment to clinical research has provided The Heart House physicians with the ability to provide their patients with the most current and cutting edge treatments available in cardiology today. The department is staffed by a highly-trained, experienced team of full-time clinical research nurse coordinators and support staff who place patient safety and care as their number one priority.

Research studies rely on volunteers to test these new investigational treatments. In order to be eligible to participate in a study, volunteers must meet specific criteria. The criteria help to focus the specific medical population being studied, minimize variables and provide patient safety. Clinical research study volunteers assist in the advancement of science and help develop medical therapies that may someday offer better treatments for future cardiology patients.

Active Areas of Research

• Atrial Fibrillation
• Gene Therapy for Advanced Coronary Disease
• Mitra-Clip for Severe Mitral Regurgitation
• Type 2 Diabetes Mellitus
• Heart Attack or Angina
• Pacemaker Implantation
• Defibrillator Implantation
• Coronary Artery Stenting

Currently Enrolling Clinical Research Trials

OUT PATIENT (OFFICE SITES)

CAMELLIA – TIMI 61:  A Randomized, Double-Blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment with BELVIQ on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects with Cardiovascular Disease or Multiple Cardiovascular Risk Factors.” Principal Investigators:  Harvey Snyder, MD (Haddon Heights); Dilip Viswanath, MD (Sewell); Mark Gelernt, MD (Elmer)

COMMANDER:  A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure. Principal Investigators:  Mark Gelernt, MD (Elmer); Dilip Viswanath, MD (Sewell); Harvey Snyder, MD (Haddon Heights)

ELITE:  Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients (ELITE). Principal Investigators:  Mark Gelernt, MD (Elmer)

GENETIC AF:  A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure. Principal Investigator:  Mark Gelernt, MD (Elmer)

OAT:  Safety of Oral Anticoagulation Therapy withdrawal after Successful Cardiac Ablation in Patients with Atrial Fibrillation and Associated High Risk Factors for Embolic Events  (OAT Pilot Study). Principal Investigator:  George Mark, MD (Haddon Heights, Elmer, Sewell, Marlton, and Vineland)

PIONEER HF:  A multicenter, randomized, double-blind, double dummy, parallel group, active-controlled 8-week study to evaluate the effect of sacubitril/valsartan (LCZ696) versus enalapril on changes in NT-proBNP and safety and tolerability of in-hospital initiation of LCZ696 compared to enalapril in HFrEF patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF). Principal Investigators:  Sanford Gips, MD (Haddon Heights and Cooper University Hospital);  Mark Gelernt, MD (Elmer, Vineland, and Inspira Health Network)

STRENGTH:  A Long-Term Outcomes Study to Assess Statin Residual Risk Reduction with EpaNova in High Cardiovascular Risk Patients with Hypertriglyceridemia. Principal Investigators:  Dilip Viswanath, MD (Sewell); Mark Gelernt, MD (Elmer); Harvey Snyder, MD (Haddon Heights)  

VICTORIA:  A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF). Principal Investigator:  Dilip Viswanath, MD –Sewell  

PERSPECTIVE:  A multicenter, randomized, double-blind, active-controlled study to evaluate the effects of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Principal Investigators:  Mark Gelernt, MD – Elmer; Dilip Viswanath, MD – Sewell; Harvey Snyder, MD – Haddon Heights

CLEAR:  A randomized, double-blind, placebo controlled study to assess the effects of bempedoic acid (ETC-1002) on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease who are statin intolerant. Principal Investigator:  Dilip Viswanth, MD – Sewell; Harvey Snyder, MD – Haddon Heights 

INVESTED:  Influenza vaccine to effectively stop cardiothoracic events and decompensated heart failure. Principal Investigators:  Mark Gelernt, MD – Elmer; Dilip Viswanath, MD – Sewell; Harvey Snyder, MD – Haddon Heights

IN-PATIENT (HOSPITAL SITES)

AMULET:  Amplatzer™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial. Sub Investigators:  George Mark, MD, George Kaddissi, MD – Cooper University Hospital

ASAP TOO:  Assessment of the WATCHMANTM Device in Patients Unsuitable for Oral Anticoagulation. Principal Investigator:  George Mark, MD – Cooper University Hospital

 PIONEER III:  A Prospective Multicenter Global Randomized Controlled Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients with Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndrome. Principal Investigators:  Vijayendra Verma, MD – Our Lady of Lourdes Medical Center; Georges Kaddissi, MD – Cooper University Hospital

ABSORB RCT:  A clinical evaluation of ABSORBTM­­­­­­­­­­­ BVS, Everolimus Bio-Resorbable Vascular Scaffold, in the treatment of subjects with de novo native Coronary Artery Lesions. Principal Investigators: Georges Kaddissi, MD – Cooper University Hospital; Vijayendra Verma, MD – Our Lady of Lourdes Medical Center

SAFE DCB:  A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (SAFE-DCB U.S. Registry). Principal Investigator:  Vijayendra Verma, MD – Our Lady of Lourdes Medical Center

ARTEMIS:  Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study. Principal Investigator:  Georges Kaddissi, MD – Cooper University Hospital; Vijayendra Verma, MD – Our Lady of Lourdes Medical Center

EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY™ Stent System) for the Treatment of Atherosclerotic Lesion(s). Principal Investigator: Kartik Giri, MD – Our Lady of Lourdes Medical Center

OPEN STUDY:  Evaluation of Safety and Efficacy of the FlexStent® Femoro-popliteal Self-Expanding Stent System Study. Principal Investigators:  Vijay Verma, MD – Our Lady of Lourdes Medical Center); Georges Kaddissi, MD – Cooper University Hospital

SURTAVI:  Surgical Replacement and Transcatheter Aortic Valve Implantation. Sub-Investigator:  Georges Kaddissi, MD – Cooper University Hospital

EP Clinical Trials 

APPRAISE ATP:  Assessment of primary prevention receiving an ICD systematic evaluation of ATP. Principal Investigator:  George Mark, MD – Haddon Heights, Marlton, Sewell, and Elmer

GALAXY: Registry to assess long-term safety of Biotronik’s family of ICD leads in conjunction with its pulse generators.  Evaluation will be based on adverse event analysis of the Linox Lead System.  Registry will also provide data to permit characterization of any ICD lead failures contributing to loss of bradycardia or shock therapy. Principal Investigator: George Mark, MD  

QUAD PAS:  Evaluation of the acute and chronic performance of a quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy. Principal Investigator: George Mark, MD – Cooper University Hospital         

INGEVITY:  A prospective, non-randomized, multi-center, global clinical study to establish the safety, performance and effectiveness of the INGEVITY active and passive fixation pace/sense leads. Principal Investigator: George Mark, MD – Cooper University Hospital

S-ICD:  S-ICD® System Post Approval Study. Principal Investigator: George Mark, MD – Our Lady of Lourdes Medical Center

SIELLO:  This clinical study is a combined Pre-Market Study and Post-Approval Registry Involving subjects implanted with BIOTRONIK’s SIELLO pacing lead in the atrium and/or ventricle. Principal Investigator:  George Mark, MD – Our Lady of Lourdes Medical Center

NAVIGATE: Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads (NAVIGATE X4). Principal Investigator:  George Mark, MD – Cooper University Hospital

OPTISURE:  Optisure Lead Post Approval Study. Principal Investigator: Steven DaTorre, MD (Haddon Heights, Sewell, Elmer & Marlton)

LSS 4SITE:  The Longitudinal Surveillance Study of the 4-SITE Lead/Header System. Principal Investigator:  George Mark, MD (Haddon Heights, Sewell, Elmer, & Marlton)  

ADAPT Response:   A Prospective, Randomized, Controlled, Interventional, Single-blinded, Multi-center, Post-market, Global Cardiac Resynchronization Therapy (CRT) in Heart Failure (HF) Clinical Study. Sub- Investigators: George Mark, MD, Steven Levi, MD – Our Lady of Lourdes Medical Center

WRAP IT:  World-wide Randomized Antibiotic Envelope Infection Prevention Trial. Sub-Investigators:  Steven Levi, MD, George Mark, MD – Our Lady of Lourdes Medical Center

UNTOUCHED: Understanding Outcomes with the EMBLEM™ S-ICD in Primary Prevention Patients with Low Ejection Fraction. Principal Investigator:  George Mark, MD – Cooper University Hospital

SMART CRT:  Strategic Management to Optimize Response To Cardiac Resynchronization Therapy. Principal Investigator:  George Mark, MD – Our Lady of Lourdes Medical Center

MADIT S-ICD:  Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator. Principal Investigator:  George Mark, MD – Our Lady of Lourdes Medical Center