Heart & Vascular Research - WellSpan Health
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Heart & Vascular Research

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Heart & Vascular Care Backed by Innovative Research

WellSpan’s Heart and Vascular Research Department, along with Wellspan Cardiology, Cardiac Surgery and Vascular Surgery, actively participate in clinical trials from around the world.

Our physicians also develop and conduct their own research exclusively for WellSpan patients. These research projects are supported by the Heart and Vascular Research Department from the early development stages through study completion, and are conducted in the same ethical and safety standards as our large clinical trials.

To learn more about our heart and vascular clinical trials, call us at (717) 851-3472.


How We Can Help

Researchers are identifying the newest and most effective treatment methods for cardiovascular disease through these carefully designed and conducted clinical trials. These advances help patients to live longer and better lives.

We are currently enrolling patients in the following trials. Learn more about these trials at ClinicalTrials.gov.

WellSpan Ephrata Community Hospital & WellSpan Good Samaritan Hospital

TRANSFORM-HF - This trial is designed to determine the clinical effectiveness by comparing torsemide verses furosemide as treatment for heart failure.  NCT#03296813 

CONNECT-HF - This study evaluates the effects of two-quality improvement initiatives compared with usual care on heart failure outcomes at one year after discharge for hospitalized patients with heart failure. NCT#03035474.

Heart Failure/Sleep Apnea-WatchPat Study - This trial will evaluate the use of home sleep technology in patients who have a diagnosis of congestive heart failure and have screened positive for sleep apnea.

WellSpan York Hospital

DRUG STUDIES

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. (NCT 02929329)

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. (NCT 02924727)

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 (NCT 02993406)

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. (NCT 03057977)

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 (NCT 03057951)

 

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). (NCT 02675114)

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. (NCT 03042104)

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 (NCT 02879448)

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. (NCT 02928497)

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). (NCT 02661451)

NOVACROSS - A prospective, multi-center, non- randomized, single arm, open label, pivotal study to evaluate the safety and effectiveness of the NovaCross Micro-catheter in facilitating crossing chronic total occlusion (CTO) Coronary lesions. (NCT 03719014)

CHOCOLATE TOUCH STUDY - A Randomized Trial to confirm the safety and effectiveness of Chocolate Touch Paclitaxel Coated PTA Balloon Catheter, in above the knee lesions. (NCT 02924857)

 

INVESTIGATOR INITIATED

WellSpan Cardiologists designed and oversee these studies.

TAVR-PREHAB - Prehabilitation for patients undergoing transcatheter aortic valve replacement. Study also being conducted at Gettysburg Hospital (NCT 03107897)

SLEEP STUDY - Use of home sleep technology on inpatient heart failure patients for greater diagnostic yield and patient centeredness.

 

REGISTRY

PRECISION GRX Registry - A multicenter post market registry for the evaluation of the CorPath GRX System effectiveness in percutaneous coronary interventions. (NCT 03278301)

RELEASE - Transvenous Lead Removal Using the Cook Evolution Lead Extraction System-Post Market Clinical Study Global Clinical Number: 16-04 (NCT 03688412)