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NCT06777368 · ClinicalTrials.gov registry record
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
A clinical trial of Aortic Stenosis, sponsored by Medtronic Cardiovascular.
- Recruiting
- Registry status
- 225
- Enrollment target
- 20
- Study locations
NCT06777368: Recruiting study of Aortic Stenosis, sponsored by Medtronic Cardiovascular.
NCT06777368 is a study of Aortic Stenosis that is actively recruiting participants, run by Medtronic Cardiovascular. The registered enrollment target is 225 participants, below the 1,354-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06777368, a study of Aortic Stenosis, is actively recruiting participants, sponsored by Medtronic Cardiovascular.
- RECRUITING
- Registry status
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Primary Outcome
30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device
Conditions Studied
Interventions
- DEVICE Medtronic TAV
- DEVICE Edwards TAV
Study Locations (20)
California
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Sutter Heatlh - Sacramento
- Kaiser Permanente Northern California - Sacramento
- Stanford Hospital & Clinics - Stanford
- Los Robles Regional Medical Center - Thousand Oaks
Florida
- Morton Plant Hospital - Clearwater
- HealthPark Medical Center, Lee Memorial Health - Fort Myers
- Orlando Health/Orlando Regional Medical Center - Orlando
- Tampa General/USF - Tampa
Arizona
- Abrazo Arizona Heart Hospital - Phoenix
- Tucson Medical Center - Tucson
Connecticut
- Hartford Hospital - Hartford
- Yale New Haven Hospital - New Haven
Indiana
- Parkview Health - Fort Wayne
- Saint Vincent Heart Center of Indiana - Indianapolis
Iowa
- MercyOne Iowa Heart Center - Des Moines
- University of Iowa Hospitals and Clinics - Iowa City
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Medical Center of the Rockies - Loveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2033-07 |
What NCT06777368 shows while recruiting
NCT06777368 is an observational study that tracks outcomes without assigning an intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 1,354-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Aortic Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Medtronic TAV is the first listed.
NCT06777368 names 20 study sites across 9 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06777368 about?
NCT06777368 is a clinical study titled "REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE". The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
What is the current status of trial NCT06777368?
This trial is currently recruiting. The enrollment target is 225 participants. The study started on 2025-02-06. Estimated completion is 2033-07.
What conditions does trial NCT06777368 study?
This clinical trial studies the following conditions: Aortic Stenosis.
What interventions are being tested in trial NCT06777368?
The interventions under investigation include: Medtronic TAV (DEVICE), Edwards TAV (DEVICE).
Who is sponsoring clinical trial NCT06777368?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06777368 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aortic Stenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06777368's enrollment target sits among peer trials
225 14th of 26 higher than 13 of 26 other Aortic Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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