Interventional Structural Heart Disease Research

CORCINCH-HF: Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Summary: The purpose of this clinical study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

• Primary Investigators: Ignacio Inglessis-Azuaje, MD
• Study Population or Disease Focus: Patients with heart failure and reduced ejection fraction (HFrEF)
• Status: Enrolling
• Source: Industry-initiated

The Global cVAD Study

Summary: The intent of the Global cVAD Study is to utilize observational data of hemodynamic support devices in real-world settings to drive best practice usage patterns identified through study analysis.

• Primary Investigators: Igor Palacios, MD and David D'Alessandro, MD
• Study Population or Disease Focus: Patients requiring hemodynamic support via an Impella Device
• Status: Enrolling
• Source: Industry-initiated

Novel Markers of Myocardial Injury

Summary: Patients undergoing alcohol septal ablation for hypertrophic cardiomyopathy have blood collected at certain time points for analysis.

• Primary Investigator: Michael A Fifer, MD
• Study Population or Disease Focus: Patients with hypertrophic cardiomyopathy
• Status: Enrolling
• Source: PI-initiated

Summary: Randomized controlled study of the Occlutech Flex II PFO closure device, compared to Amplatzer or Gore PFO closure devices, in patients with a patent foramen ovale who have suffered from a cryptogenic stroke or transient ischemic attack.

• Primary Investigator: Ada Stefanescu, MD MS
• Study Population: Adults who suffered a PFO-related stroke or TIA
• Status: Enrolling
• Source: Industry-initiated

REDUCE PAS: GSO 18-01. 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

Summary: The REDUCE PAS study is for patients with a history of cryptogenic stroke (stroke of unknown cause) who also have a patent foramen ovale, or a small hole between the two upper chambers of the heart. With a device that is fed up into the heart through vessels in the groin, doctors can close the PFO, which helps prevent future strokes. Gore REDUCE PAS is a post-market approval study, meaning the closure device used in the study has already been approved by the U.S. Food and Drug Administration. The purpose of the research is to continue to collecting data on the device, even after FDA approval, and to learn more about PFO closure.

• Primary Investigator: Ignacio Inglessis-Azuaje, MD
• Study Population or Disease Focus: PFO patients with cryptogenic stroke (of unknown cause) in the past year
• Status: Enrolling
• Source: Industry-initiated

RELIEF: GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches

Summary: RELIEF is a multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief in patients with a presence of PFO who experience migraine headaches.

• Primary Investigator: Ignacio Inglessis-Azuaje, MD
• Study Population or Disease Focus: Patients with a presence of Patent Foramen Ovale (PFO) who experience migraine headaches
• Status: Enrolling
• Source: Industry-initiated