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.
Currently Enrolling Clinical Research Trials
Outpatient (Office)
» ACCELERATE: Assessment of Clinical Effects of Cholestryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes
Principal Investigators: Mark Gelernt, MD (Elmer); Harvey Snyder, MD (Haddon Heights); Jeffrey Kramer, MD (Sewell)
» EUCLID: A randomized, double-blinded, parallel group, multicenter phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease.
Principal Investigators: Mark Gelernt, MD (Elmer); Harvey Snyder, MD (Haddon Heights); Jeffrey Kramer, MD (Sewell)
» TECOS: A randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control.
Principal Investigators: Mark Gelernt, MD (Elmer); Harvey Snyder, MD (Haddon Heights)
» HPS 3/TIMI 55 - REVEAL: (Randomized Evaluation of the Effects of anacetrapib through Lipid-modification) A large scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease.
Principal Investigators: Mark Gelernt, MD (Elmer); Andreas Pavlides, MD (Haddon Heights); Dilip Viswanath, MD (Sewell)
» PEGASUS: A Randomized. Double- Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Preventions of Thrombotic Events with Ticagrelor Compared to Placebo on a background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infraction
Principal Investigator: Mark Gelernt, MD (Elmer)
» ORBIT: Outcome Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
Principal Investigators: Mark Gelernt, MD (Elmer); Harvey Snyder, MD (Haddon Heights); Jeffrey Kramer, MD (Sewell)
» 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)
» 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)
» BI 1160.128: A prospective open label study evaluating the efficacy of two management strategies (pantoprazole 40mg q am and taking Pradaxa® within 30 minutes after a meal) on gastrointestinal symptoms (GIS)I patients newly on treatment with Pradaxa® for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Principal Investigator: Mark Gelernt, MD (Elmer)
» Apixaban PDx: A Phase 0, Nonrandomized, Blood Sampling Study for Investigational Assay Development in Patients Currently Treated with Apixaban
Principal Investigator: Dilip Viswanath, MD (Sewell & Haddon Heights)
» GUIDE IT: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (CCC) in Heart Failure
Principal Investigator: Mark Gelernt, MD
» 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)
Inpatient (Hospital)
» RENEW: A prospective, randomized, double-blinded, active-control and un-blinded standard of care (SOC) controlled study to determine the efficacy and safety of targeted intra-myocardial delivery of autologous CD34+ cells (Auto-CD34+ cells) for increasing exercise capacity during standardized exercise testing in subjects with refractory angina pectoris and chromic myocardial ischemia (CMI)
Principal Investigator: Vijay Verma. MD — Our Lady of Lourdes Medical Center
» ABSORB RCT: A clinical evaluation of ABSORB™ BVS, Everolimus Bio-Resorbable Vascular Scaffold, in the treatment of subjects with de novo native Coronary Artery Lesions.
Principal Investigators: Georges Kaddissi, MD — Cooper Hospital; Vijay 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
» PIONEER: An Open-label, Randomized, Controlled, Multicenter study Exploring Two Strategies of Rivaroxaban and a Dose adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
Principal Investigator: Vijay Verma, 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 Hospital)
» LEVANT II: A prospective, multicenter, single blind, randomized, controlled trial comparing the Moxy™ drug coated balloon vs. standard balloon angioplasty for treatment of femoropopliteal arteries.
Principal Investigators: Kartik Giri, MD; Vijay Verma, MD; George Kaddissi, MD;
Andrew Zinn, MD — Our Lady of Lourdes Medical Center
» TAXUS LIBERTE: Post approval study of the TAXUS Liberte paclitaxel-eluting coronary stent system.
Principal Investigator: Kartik Giri, MD — Our Lady of Lourdes Medical Center
» PLATINUM: A randomized trial to assess Everolimus-eluting coronary stent system (Promus Element) for de novo Coronary Artery Lesions.
Principal Investigator: Sanford Gips, MD — Cooper Hospital
» ION: A prospective, open label, multicenter study designed to observe clinical outcomes in subjects receiving the IONTM paclitaxel-eluting platinum chromium coronary stents
Principal Investigator: Kartik Giri, MD — Our Lady of Lourdes Medical Center
EP Clinical Trials
» MULTISENSE: Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients
Principal Investigator: George Mark, MD
» 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
» ANALYZE ST: ST Monitoring to detect ACS events in ICD patients study.
Principal Investigator: George Mark, MD — Our Lady of Lourdes Medical Center
» 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 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 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 Hospital
» OPTISURE: Optisure Lead Post Approval Study
Principal Investigators Steven DaTorre, MD (Haddon Heights, Sewell, & Elmer)
» reMARQable: nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Principal Investigators: Steven Levi, MD, 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.
Principal Investigators: George Mark, MD, Steven Levi, MD — Our Lady of Lourdes Medical Center
