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NCT05666713 · ClinicalTrials.gov registry record · NA
NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
A NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT05666713: Completed NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05666713 is a NA study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05666713, a NA study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary efficacy endpoint is technical success, which is defined when the following criteria are all met: 1. Successful electrosurgical leaflet traversal using the TELLTALE Guidewire 2. Successful electrosurgical leaflet laceration using the TELLTALE Guidewire 3. Successful retrieval of the TELLTALE Guidewire System
Interventions
- DEVICE TELLTALE BASILICA procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-02-21 |
| Est. Completion | 2025-04-25 |
| Phase | NA |
What the finished NCT05666713 record still lists
NCT05666713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which TELLTALE BASILICA procedure is the first listed.
NCT05666713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05666713 about?
NCT05666713 is a clinical study titled "NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial". 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 th...
What is the current status of trial NCT05666713?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2023-02-21. Estimated completion is 2025-04-25.
What interventions are being tested in trial NCT05666713?
The interventions under investigation include: TELLTALE BASILICA procedure (DEVICE).
Who is sponsoring clinical trial NCT05666713?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05666713's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 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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