NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Public ClinicalTrials.gov record NCT05666713. 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
NHLBI Transmural Electrosurgery LeafLet Traversal and Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: Replacing a valve in the heart can save many people's lives. The procedure is called transcatheter aortic valve replacement (TAVR). In rare cases, a flap of tissue called a leaflet can shift during TAVR; the leaflet may block blood flow to the coronary arteries, which supply blood to the heart muscle. About 50% of people who experience this problem will die. To reduce this risk, doctors will cut this leaflet during TAVR. But the tools used to cut the leaflet were originally designed for other purposes. Using these tools during TAVR can be complicated and risky. Researchers want to make TAVR safer. Objective: To test a new device (TELLTALE) designed specifically for use during TAVR. Eligibility: People aged 21 years and older who are undergoing TAVR and who are at high risk of coronary artery obstruction. Design: Participants will be screened. They will have routine tests that are done before undergoing TAVR. Before the procedure, participants will complete a questionnaire. They will talk about how their heart disease affects their quality of life. Their physical abilities and their risk of stroke will be assessed. Participants will be admitted to the hospital for TAVR. They will be placed under general anesthesia or moderate sedation. The procedure will be performed using the TELLTALE guidewire system. Participants will repeat the tests of their physical abilities after the procedure. They will also repeat the questionnaire about their quality of life. These will be repeated again at a follow-up visit in 30 days. Participants will have a final study visit after 90 days. This visit may be in person or remote.
Study identification
- NCT ID
- NCT05666713
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 109 Years
- 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
- Feb 20, 2023
- Primary completion
- Feb 13, 2025
- Completion
- Apr 24, 2025
- Last update posted
- Feb 2, 2026
2023 – 2025
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Pacific Med Ctr | San Francisco | California | 94109 | — |
| University of Colorado Health | Fort Collins | Colorado | 80528 | — |
| Medstar WHC | Washington D.C. | District of Columbia | 20010 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Rochester Regional Health | Rochester | New York | 14621 | — |
| St. Francis Hospital and Heart Center | Roslyn | New York | 11576 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Carilion Medical Center | Roanoke | Virginia | 24014 | — |
| University of Washington Heart Institute | Seattle | Washington | 98195 | — |
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 NCT05666713, 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 Feb 2, 2026 · Synced Sep 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05666713 live on ClinicalTrials.gov.