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, Vineland, Washington Township and Marlton, 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
• Mitra-Clip for Severe Mitral Regurgitation
• Type 2 Diabetes Mellitus
• Heart Attack or Angina
• Pacemaker Implantation
• Defibrillator Implantation
• Coronary Artery Stenting
  • Arrhythmias
  • Congestive Heart Failure
• Currently Enrolling Clinical Research Trials

OUT PATIENT (OFFICE SITES)

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 

DIAMOND: A Multicenter, Double-Blind, Placebo-controlled, study of Patiromer for the management of hyperkalemia in patients receiving renin-angiotensin-aldosterone system inhibitor (RAASi) medications for the Treatment of heart failure. Principal Investigator: Sanford Gips, MD – Haddon Heights

EMPACT-MI: A Streamlined, Multicenter, Double-Blind, Placebo-controlled superiority trial to evaluate the effect of Empagliflozin on hospitalization for heart failure and mortality in patients with acute myocardial Infarction. Principal Investigators: Mark Gelernt, MD – Elmer; Vijayendra Verma, MD – Haddon Heights

NODE-303: Multicenter, Open Label, Safety study of Etripamil nasal spray for patients with Paroxysmal Supraventricular Tachycardia. Principal Investigator: George Mark, MD – Haddon Heights / Elmer

HPS-4/TIMI 65/ORION-4: A Double-Blind randomized placebo-controlled trial assessing the effects of Inclisiran on clinical outcomes among patients with atherosclerotic cardiovascular disease. Principal Investigators: Andreas Pavlides, MD – Haddon Heights; Dilip Viswanath, MD – Sewell

SPIRRIT-HFpEF: Initiation of Spironolactone in a Registry Randomized Interventional Trial for Heart Failure Patients with Preserved Ejection Fraction. Principal Investigator: Andreas Pavlides, MD – Haddon Heights

SURPASS CVOT (I8F-MC-GPGN): Event-driven, multicenter, randomized, double-blind, active comparator, parallel-group study to assess the effect of once weekly Tirzepatide (up to 15 mg) versus Dulaglutide (1.5 mg) on Cardiovascular outcomes when added to the standard of care in patients with Type 2 Diabetes Mellitus with established cardiovascular disease (CVD) and elevated risk for Major Adverse Cardiovascular Events. Principal Investigator: Sanford Gips, MD – Haddon Heights

METEORIC-HF: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in patients with Heart Failure with Reduced Ejection Fraction and Decreased Exercise Tolerance. Principal Investigator: Mark Gelernt, MD – Elmer

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 ABSORB^TM­­­­­­­­­­­ 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

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

AEGIS-II (CSL112-3001): Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group Study to Investigate the Efficacy and Safety of CSL112 in Patients with Acute Coronary Syndrome. Principal Investigators: Sanford Gips, MD – Cooper University Hospital; Vijayendra Verma, MD – Virtua Our Lady of Lourdes Medical Center; Mark Gelernt, MD – Inspira Vineland Medical Center

PARAGLIDE-HF (CLCZ696DUS01): A multicenter, randomized, double-blind, parallel group, active controlled 8-week study to evaluate the effect of Sacubitril/Valsartan (LCZ696) versus Valsartan on changes in NT-proBNP and safety and tolerability of in hospital initiation of LCZ696 compared to Valsartan in HFpEF patients with acute decompensated heart failure (ADHF) who have been stabilized during hospitalization. Principal Investigators: Mark Gelernt, MD – Inspira Medical Centers; Sanford Gips, MD – Cooper University Hospital

OPTION: A prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after Atrial Fibrillation ablation. Principal Investigator: George Mark, MD – Cooper University Hospital

CATALYST: A Prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer™ Amulet™ device in patients with non-valvular atrial fibrillation who are at increased risk for cardioembolic events. Principal Investigator: George Mark, MD – Cooper University Hospital

SAFE-STEMI for SENIORS: Study of Access Site for Enhancing PCI in STEMI for Seniors. Principal Investigators: Sanford Gips, MD – Cooper University Hospital; Vijayendra Verma, MD – Virtua Our Lady of Lourdes

EMPULSE: A multicenter, randomized, double-blind, 90-day superiority trial to evaluate the effect on clinical benefit, safety and tolerability of once daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalised for acUte heart faiLure (de novo or decompensated chronic HF) who have been Stabilized. Principal Investigators: Mark Gelernt, MD – Inspira Medical Centers; Dilip Viswanath, MD – Jefferson Washington Township Hospital; Sanford Gips, MD – Cooper University Hospital

DAPA ACT HF-TIMI 68: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients with Heart Failure with Reduced Ejection Fraction Who have been stabilized during hospitalization for Acute Heart Failure. Principal Investigators: Mark Gelernt, MD – Inspira Medical Centers; Sanford Gips, MD – Cooper University Hospital; Dilip Viswanath, MD – Jefferson Washington Township 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

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

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

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

OPTIMIZER SMART Post-Approval Study: A prospective, multi-center, non-randomized, single arm open label study of patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45% receiving an Optimizer implant as standard of care.

Additional Update to the research professional team:

Research 
Director: Erin Siderio
Donna Cockrell, RN, BSN, CCRC
Maureen Davis, MLT
Sue Manga
Kaitlyn Downey
Louise Pantuck, RN, CCRC
Amanda Salvatore, RN, BSN, CCRP
Elizabeth Watson, RN, BSN
Traci Vogt, RN, CCRC