Why This Study?
Most patients who need open heart surgery to replace a diseased aortic valve choose a biological heart valve prosthesis. These prostheses wear out over time, and another intervention due to structural deterioration may become necessary.
For decades, a second open-heart surgery was the only effective treatment option. With the advent of catheter-based aortic valve replacement procedures, these techniques were also utilized to help patients suffering from worn-out bioprostheses. The vastly reduced invasiveness of these catheter-based procedures made them increasingly popular for patients and clinicians around the world.
Although the short-term clinical benefit appears convincing, the long-term efficacy compared to redo open-heart surgery remains unclear. A rigorous comparison between these two procedures has not yet been studied within the gold-standard of medical testing, a randomized clinical trial. Hence, the goal of the REPEAT (REpeat Intervention for Failed Surgical BioProsthEtic AorTic Valves) trial is to determine which strategy provides the best long-term outcome. It is the only randomized clinical trial in the world focusing on failed biological heart valve prostheses and will help thousands of patients to receive the best treatment for a deteriorated surgical aortic bioprosthesis.
Our Affiliates
Which procedures are compared?
Which procedures are compared?
Within this trial, patients are randomly assigned to undergo either redo open-heart surgery or valve-in-valve transcatheter aortic valve replacement.
During redo open-heart surgery, the patient's chest is opened, the worn-out bioprosthesis is explanted and replaced by a new surgical bioprosthesis, using cardiopulmonary bypass and full anesthesia.
During valve-in-valve transcatheter aortic valve replacement, a stent valve mounted to a catheter is forwarded into the worn-out bioprosthesis. When in place, it is expanded, while pushing the old valve leaflets aside. This is performed mostly through vessels in the groin while the patient is under slight sedation.
Principal Investigators
We are some of the world's leading researchers, surgeons, academics and practitioners. We are on a mission to help patients who need a second chance, a new lease on life; hence our name being The REPEAT Trial.
Matthias Raschpichler, MD, PhD
Cardiac Surgeon
Heart Center Leipzig, Germany
Stefan Blankenberg, MD
Professor of Cardiology
Heart Center Hamburg, Germany
Raj Makkar, MD
Professor of Cardiology
Director Interventional Cardiology at Cedars-Sinai Medical Center, Los Angeles, CA
Michael A. Borger, MD, PhD
Professor of Cardiac Surgery
Medical Director Heart Center Leipzig, Germany
Tsuyoshi Kaneko, MD
Professor of Cardiac Surgery
Chief, St. Louis, USA
Marcio Diniz, PhD
Associate Professor of Statistics
Mount Sinai, New York
Martin Ng, MD, PhD
Professor of Interventional Cardiology
Sydney, Australia
Enoch Akowuah, MD
Professor of Cardiac Surgery
Newcastle, UK
The Narrative
The concept of the REPEAT study originated in 2019, when clinicians and researchers from the Heart Center Leipzig in Leipzig, Germany, and the Smidt Heart Institute at Cedars-Sinai Medical Center in the USA collaborated on scientific projects. It became clear that a relevant gap of knowledge existed about how to treat worn-out aortic bioprostheses. Subsequently, a clinical trial was designed to fulfill the highest standards of scientific rigor and integrity, and to ensure independence and objectivity, peer-reviewed funding from public agencies has been established.
We grouped a team of medical and scientific experts to bring the brightest minds to the table. Our primary objective is to improve the quality and longevity of life for patients facing this condition by gathering the most robust medical evidence available. We are deeply honored to serve patients worldwide in this trial; their bravery and willingness to participate is what makes this research possible.