Registry for patients needing redo transcatheter heart valve implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to evaluate the short- and long-term outcomes of patients undergoing redo transcatheter aortic valve implantation (redo-TAVI) due to failure of a previously implanted transcatheter heart valve (THV). It will collect data on procedural success, safety, and functional outcomes at 30 days and 1 year post-procedure. The study focuses on patients with structural valve deterioration and aims to provide insights into the efficacy of redo-TAVI in a multicenter setting. The findings will help establish best practices for managing patients requiring re-treatment for THV failure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Consecutive patients fulfilling the following criteria:

1. Consenting adult patient (≥18 years)
2. Procedural success of the first TAVI
3. TAVI device failure of the index THV, irrespective of SVD severity
4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)

Exclusion Criteria:

1. Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
2. Life expectancy below 12 months
3. Patients with largely incomplete data with respect to the aims of the project
4. Pregnant women at the time of the redo-TAVI

Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.

Where it's running

• LKH-University Hospital and Medical University of Graz
  Graz, Austria Recruiting
• Kepler University Clinic Linz
  Linz, Austria Recruiting
• University Hospital St. Pölten
  Sankt Pölten, Austria Recruiting
• Medical University of Vienna
  Vienna, Austria Recruiting
• McGill University Health Centre
  Montreal, Canada Recruiting
• Institut Universitaire de Cardiologie et de Pneumologie
  Québec, Canada Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Giuseppe Tarantini, Prof. — University of Padua Medical School, Padua, Italy
• Study coordinator: Claudia Lüske, PhD
• Email: claudia.lueske@ippmed.de
• Phone: 044718503324

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tipmed Revision Hip Prosthesis: 24-Month Post-Market Follow-Up

  This PMCF study tests the safety and how well the Tipmed Revision Hip Prosthesis works in adults undergoing hip revision surgery.

  Recruiting at 4 sites TIPMED Medical Device Manufacturing Ltd. Co. · Balıkesir and 3 other locations · NCT07653295

• Comparing two types of transcatheter aortic valves for patients with valve deterioration

  This study is testing which of two types of heart valves works better for patients who need a replacement due to valve problems.

  Recruiting at 12 sites Fundación EPIC · Alessandria and 11 other locations · NCT06049654

• Optimizing heart valve function using echocardiography or catheterization after valve replacement

  This study is testing whether using ultrasound or a catheter to check heart valve function after a replacement helps patients with aortic valve problems feel better and have better outcomes.

  Recruiting at 5 sites Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · San Francisco, California and 6 other locations · NCT05459233

• Evaluating the MobileLink Hip Prosthesis System Outcomes

  This study is looking at how well the MobileLink hip replacement system works and how satisfied patients are after getting it.

  Recruiting at 2 sites Waldemar Link GmbH & Co. KG · Kiel and 1 other locations · NCT04688593

• Evaluating the Vantage Mobile Bearing Total Ankle System after surgery

  This study is testing how well the Vantage Mobile-Bearing Total Ankle System works and if it's safe for people who have had ankle replacement surgery, by following them for up to 10 years after their operation.

  Recruiting at 2 sites Exactech · Santa Cruz de Tenerife and 1 other locations · NCT05691868

• Evaluating the Vantage Total Ankle System after surgery

  This study is testing how well the Vantage Total Ankle System works and its safety for people who have had ankle replacement surgery, following them for up to 10 years.

  Recruiting at 2 sites Exactech · Jacksonville, Florida and 1 other locations · NCT05619588

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.