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Evolut™ EXPAND TAVR II Pivotal Trial
NCT05149755 · View on ClinicalTrials.gov ↗
Study Summary
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05149755
The ClinicalTrials.gov registry entry for NCT05149755 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05149755 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05149755?
This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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