Cardiovascular Research and Clinical Trials

Advances in medicine and science are the result of new ideas and approaches developed through research. Cardiovascular clinical trials are carefully designed studies conducted to determine optimal treatment methods and improve the quality of life for patients.

WellSpan’s Cardiovascular Research Department and Cardiac Diagnostic Associates participate in numerous clinical trials.

WellSpan York Hospital

Contact Heart & Vascular Research 717-851-3472

DRUG STUDIES

DalGene Study - The Dal-GenE Trial: The goal of the Dal-Gene study is to evaluate the effect of dalcetrapib only in subjects who have the AA genetic variant.  Subjects will undergo a screening genetic test to determine if they have the AA genetic variant. Only those with the AA genetic variant can participate in the study.

GALACTIC HF - The GALACTIC TRIAL (Goal Directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study) is a prospective, randomized, interventional controlled trial. Designed to determine whether an early goal-directed decrement of preload and afterload with a target systolic blood pressure of 90-110 mmHg by aggressive vasodilatation in patients with acute HF in the non-ICU setting is safe, and leads to a better clinical and economical outcome.

PARADISE MI - The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to Ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF..

CLEAR OUTCOMES - People who are unable to take statin medications due to side effects may be eligible for a clinical research study.  This study is being conducted to evaluate the safety and effectiveness of an investigational medication that may help to reduce the occurrence of major Cardiovascular Disease (CVD) events such as heart attacks and strokes in patients with or at risk for CVD, who are also statin intolerant

EMPEROR REDUCED - The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

EMPEROR PRESERVED - The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction

 

DEVICE STUDIES

PARTNER 3 CAP REGISTRY - To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

EARLY TAVR - The EARLY TAVR (Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) trial is a prospective, randomized, controlled, multicenter study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 THV (Edwards Lifesciences) or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

AMULET - AMPLATZER The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant

ASAP TOO - The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke.  Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.

TAVR UNLOAD - The TAVR UNLOAD trial is an international, multi-center, randomized, open-label, clinical trial comparing the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) with the SAPIEN 3 Valve and optimized heart failure therapy (OHFT) versus OHFT in heart failure (HF) patients, with moderate aortic stenosis (AS).

EVOLVE 48 - A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Subjects with Atherosclerotic Lesion(s)

PINNACLE FLX - The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative. (enrollment is close to completion)

 

REGISTRY

UPSTREAM - A prospective, multicenter, observational registry of patients with a working diagnosis of NSTEMI and treatment with ticagrelor, clopidogrel, or prasugrel 4-72 hours upstream of diagnostic angiography.  Patients are consented in the hospital and studied through discharge, and patients discharged on ticagrelor will be followed for an additional 30 days.


WellSpan Ephrata Community Hospital

Contact Heart & Vascular Research at 717-738-0167 option 4

UPSTREAM - A prospective, multicenter, observational registry of patients with a working diagnosis of NSTEMI and treatment with ticagrelor, clopidogrel, or prasugrel 4-72 hours upstream of diagnostic angiography.  Patients are consented in the hospital and studied through discharge, and patients discharged on ticagrelor will be followed for an additional 30 days.


WellSpan Good Samaritan Hospital

Contact Heart & Vascular Research at 717-738-0167 option 4

CONNECT-HF - A large-scale, pragmatic, cluster-randomized trial to evaluate a customized, multifaceted, health system-level quality-improvement program, compared with usual care on Heart Failure outcomes, to move evidence into practice and improve downstream outcomes.  Patients are consented in the hospital and followed for 12 months.

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