Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
Public ClinicalTrials.gov record NCT03635424. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Study identification
- NCT ID
- NCT03635424
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 30, 2018 (Actual)
- Primary completion
- Nov 13, 2019 (Actual)
- Completion
- Dec 2030 (Estimated)
- Last update posted
- May 5, 2026
2018 – 2030
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Abrazo Arizona Heart Hospital | Phoenix | Arizona | 85016 | — |
| Scripps Memorial Hospital La Jolla | La Jolla | California | 92037 | — |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| HealthPark Medical Center | Fort Myers | Florida | 33908 | — |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Spectrum Health Hospital | Grand Rapids | Michigan | 49503 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| The Mount Sinai Hospital | New York | New York | 10029 | — |
| Saint Francis Hospital | Roslyn | New York | 11576 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Oregon Health & Science University Hospital | Portland | Oregon | 97239 | — |
| UPMC Pinnacle Harrisburg Campus | Harrisburg | Pennsylvania | 17101 | — |
| Paramount Heart | Villanova | Pennsylvania | 19085 | — |
| Baylor Jack and Jane Hamilton Heart & Vascular Hospital | Dallas | Texas | 75226 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03635424, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03635424 live on ClinicalTrials.gov.