Redo Transcatheter Aortic Valve Replacement for valve failure

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 study aims to gather clinical evidence regarding the safety and performance of redo Transcatheter Aortic Valve Replacement (TAVR) in patients experiencing valve failure. It focuses on assessing both acute and long-term outcomes associated with this procedure, as well as identifying factors that may influence these outcomes. The study involves patients who have undergone previous TAVR procedures and are now facing complications requiring a second intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Exclusion Criteria:

* BVF due solely to paravalvular regurgitation
* Active endocarditis
* Untreated acute valve thrombosis
* Life-expectancy less than 1-year
* Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
* Participating in another study that may influence the outcome of this study

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Abrazo Arizona Heart Hospital
  Phoenix, Arizona, United States Recruiting
• Kaiser Permanente Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Sutter Heatlh
  Sacramento, California, United States Recruiting
• Kaiser Permanente Northern California
  Sacramento, California, United States Recruiting
• Stanford Hospital & Clinics
  Stanford, California, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Guilherme Attizzani, MD — UH, Cleveland Medical Center
• Study coordinator: RESTORE Study Clinical Team
• Email: RS.RESTORESTUDY@medtronic.com
• Phone: 763 514 4000

Similar studies

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

• Exercise and nutrition support before and after TAVI for older adults with aortic stenosis

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• Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI

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• Systematic 14-day ambulatory heart monitoring after TAVI

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  Recruiting at 4 sites Azienda Ospedaliera "Sant'Andrea" · Bologna and 4 other locations · NCT07620925

• TAVI without on-site heart surgery: can selected centers do it safely?

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• Willem AI for early detection of aortic stenosis from a 12‑lead ECG

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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.