Randomized Evaluation for Failed TAVR

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · May 1, 2024

Keywords

ClinConnect Summary

The REVIVE TAVR clinical trial is studying two treatment options for patients who have experienced problems with their heart valve replacement, specifically those who have had a procedure called transcatheter aortic valve replacement (TAVR) that did not work as expected. The trial will compare two approaches: one where doctors place a new valve inside the old one (called redo-TAVR) and another where they remove the old valve entirely (known as TAVR-explant). This research aims to find out which method is safer and more effective for patients who are experiencing symptoms due to their valve failure.

To be eligible for this trial, participants should be between 65 and 80 years old, have been confirmed by a medical team as suitable for either treatment option, and show symptoms related to their faulty heart valve. Participants will need to agree to follow-up visits after their treatment to ensure their health is monitored. It’s important to note that patients with certain health issues, like severe infections or conditions that may prevent them from following through with the trial requirements, will not be able to participate. This trial is not yet recruiting participants, but it aims to provide valuable information about the best ways to help patients with failed heart valves.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV
• • Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II
• • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
• • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
• Exclusion Criteria:
• • Ongoing sepsis, including active endocarditis;
• • Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
• • Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
• • Pregnancy or intent to become pregnant for the next 12 months;
• Coronary obstruction risk:
• • - Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.