By studying new ways to improve heart care, clinical trials can bring innovations and new treatment strategies for cardiology patients. At Loma Linda University International Heart Institute, you have access to clinical trials by leading cardiology experts committed to giving each patient the best heart care.

Cardiology Open Studies

Interventional

Title
Description
Researcher
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
The purpose of the GORE Cardioform Septal Occluder (GSO) study is to evaluate the safety and effectiveness of the device used to close an opening in the heart between the upper chambers (atria). This trial complements the REDUCE study and assesses the quality of operator education, training and real-world experience in using the device.
https://clinicaltrials.gov/ct2/show/NCT03821129
Islam Abudayyeh, MD
Restore EF Study
Improvement in Left Ventricular Ejection Fraction and Functional Classification with Complete Revascularization with LV support.
https://clinicaltrials.gov/ct2/show/NCT04648306
Aditya Bharadwaj, MD
Diamondback 360™ Coronary Orbital Atherectomy System Registry
Multicenter registry of Outcomes of Percutaneous coronary intervention of severely calcified lesion with Orbital Atherectomy.
Aditya Bharadwaj, MD
A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study
To determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, New Myocardial Infarction, Ischemia Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure in patients who have undergone successful elective transfemoral TAVR with a balloon expandable transcatheter heart valve.
Islam Abudayyeh, MD
Assessment of the CARILLON Mitral Contour System in Treating Functional Mitral Regurgitation Associated with Heart Failure.
The objective of this prospective, randomized clinical trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with heart failure.
https://clinicaltrials.gov/ct2/show/NCT03142152
Islam Abudayyeh, MD

General Cardiology

Title
Description
Researcher
Woman’s Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR)
WARRIOR trial is a multi-site, PROBE design, that will evaluate an intensive statin/ACE-I (or ARB)/aspirin treatment strategy (IMT) vs. primary prevention risk factor therapy treatment strategy (UC) in 4,422 symptomatic (chronic angina or equivalent) women from 50 centers across the United States with non-obstructive CAD (<50% diameter narrowing) (established by cardiac catheterization or coronary CT).
https://clinicaltrials.gov/ct2/show/NCT03417388
Purvi Parwani, MD

Heart Failure

Title
Description
Researcher
Assessment of the CARILLON Mitral Contour System in Treating Functional Mitral Regurgitation Associated with Heart Failure.
The objective of this prospective, randomized clinical trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with heart failure.
https://clinicaltrials.gov/ct2/show/NCT03142152
Islam Abudayyeh, MD
A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure
Patients (PROACTIVE- HF Trial)
The Cordella PA Sensor System is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient centered heart failure management.
https://clinicaltrials.gov/ct2/show/NCT04089059
Ahmed Seliem, MD

Electrophysiology

Title
Description
Researcher
Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation OPTION
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
https://clinicaltrials.gov/ct2/show/NCT03795298
Rahul Bhardwaj, MD