Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation (Mitral ViV) Registry

Launched by MEDICAL UNIVERSITY OF WARSAW · Nov 14, 2022

Keywords

ClinConnect Summary

The Polish Transcatheter Transfemoral Mitral Valve-in-Valve Implantation Registry is a clinical trial that aims to gather important information about a new treatment for patients with failing mitral bioprosthetic valves. These valves are often used in older patients to help with heart conditions, but over time, they can stop working properly, leading to issues like narrowing (stenosis) or leakage (insufficiency). Instead of undergoing traditional surgery again, some patients may qualify for a less invasive procedure called transcatheter mitral valve-in-valve implantation (TMVR). This trial will collect data from various hospitals in Poland to better understand how this treatment works for patients and to track their recovery after the procedure.

To be eligible for this trial, patients need to have a failing mitral bioprosthetic valve that is causing significant problems, and they must be approved for the TMVR procedure by a specialized Heart Team. Participants in the study will receive TMVR and will be monitored closely to see how well the treatment helps them. This research is crucial, as it will provide insights specifically about Polish patients, helping to improve care for those facing similar heart issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• • Qualification for TMVR by decision of the local Heart Team
• • Patient provided written informed consent
• Exclusion Criteria:
• • - Disqualification from TMVR