Explore This Research Program

Overview

Structural heart diseases encompass defects and disorders that affect the structure of the heart. Often, these diseases are present from birth (congenital), but they can also develop later in life. Our clinical and translational research efforts broadly seek to improve the clinical diagnosis and management of patients with structural and adult congenital heart diseases. Much of our research specifically targets the development and improvement of minimally invasive, catheter-based procedures to treat structural and adult congenital heart diseases and translational research studies to expand our understanding of the natural history and biology of these unique diseases.

Structural Heart Disease Clinical Trials

Clinical Research Trials

cVAD

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

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
REDUCE PAS

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

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