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NCT05149755 · ClinicalTrials.gov registry record · NA
Evolut™ EXPAND TAVR II Pivotal Trial
A NA study of Moderate Aortic Valve Stenosis, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 650
- Enrollment target
- 20
- Study locations
NCT05149755: Active NA study of Moderate Aortic Valve Stenosis, sponsored by Medtronic Cardiovascular.
NCT05149755 is a NA study of Moderate Aortic Valve Stenosis that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 650 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05149755, a NA study of Moderate Aortic Valve Stenosis, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 650 participants
- Enrollment target
- 20
- Study locations
Study Summary
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
Primary Outcome
Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
Conditions Studied
Interventions
- DEVICE Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Study Locations (20)
Florida
- Morton Plant Hospital - Clearwater
- University of Florida - Gainesville
- Saint Vincent's Medical Center Riverside - Jacksonville
- Orlando Health - Orlando
- Tallahassee Memorial Hospital - Tallahassee
- Tampa General Hospital - Tampa
Massachusetts
- Tufts Medical Center - Boston
- Beth Israel Deaconess Medical Center - Boston
- Baystate Medical Center - Springfield
Arizona
- Abrazo Arizone Heart Hospital - Phoenix
- HonorHealth Scottsdale Shea Medical Center - Scottsdale
Connecticut
- Saint Vincents Medical Center - Bridgeport
- Hartford Hospital - Hartford
Alabama
- University of Alabama at Birmingham (UAB) Hospital - Birmingham
California
- Los Robles Hospital & Medical Center - Thousand Oaks
Colorado
- University of Colorado Hospital - Aurora
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2022-04-27 |
| Est. Completion | 2034-12 |
| Phase | NA |
What the registry record for NCT05149755 still lists
NCT05149755 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Moderate Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) is the first listed.
NCT05149755 names 20 study sites across 11 states, led by Florida, Massachusetts, Arizona.
Frequently Asked Questions
What is clinical trial NCT05149755 about?
NCT05149755 is a clinical study titled "Evolut™ EXPAND TAVR II Pivotal Trial". Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
What is the current status of trial NCT05149755?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 650 participants. The study started on 2022-04-27. Estimated completion is 2034-12.
What conditions does trial NCT05149755 study?
This clinical trial studies the following conditions: Moderate Aortic Valve Stenosis.
What interventions are being tested in trial NCT05149755?
The interventions under investigation include: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) (DEVICE).
Who is sponsoring clinical trial NCT05149755?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05149755 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
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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 NCT05149755's enrollment target sits among peer trials
650 156th of 2000 higher than 1,845 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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