CompletedNot Applicable

NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

United States90 participantsStarted 2023-02-21

Plain-language 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.

Who can participate

Age range21 Years – 109 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: In order to be eligible to participate in the study, candidates must meet all of the following criteria: * Adults age \>= 21 years * High or prohibitive risk of surgical aortic valve replacement according to the local multidisciplinary heart team * Undergoing TAVR for bioprosthetic aortic valve failure or native aortic stenosis ( on-label TAVR) * Local multidisciplinary heart team determines subject to be at high risk of TAVR-induced coronary artery obstruction * Deemed likely to suffer coronary artery obstruction from TAVR based on NHLBI Core lab analysis of CT, any of * Risk is narrow Sinus of Valsalva: (a) Leaflet height is greater than coronary artery height, and (b) Virtual transcatheter valve-to-coronary (VTC) distance \< 4mm * Risk is Sinus sequestration: (a) Threatening leaflet height is greater than sinotubular junction, and (b) Virtual transcatheter valve-to-sinotubular-junction distance (VTS) \< 2mm at the affected Sinus * Concurrence of the Study Eligibility Committee * Able to understand the protocol, consents in writing to participate, and willing to comply with all study procedures for the duration of the study EXCLUSION CRITERIA: * Requires doppio (two-leaflet) BASILICA * Flail target leaflet at baseline * Excessive target aortic leaflet calcification (no basal calcium-free window or potentially obstructive calcific masses) on baseline CT * Planned provisional (pre-position coronary artery) stents despite BASILICA * Requires non-…

What they're measuring

Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System

Timeframe: 1 minute following procedure discharge (Exit from the catheterization laboratory)

Number of Inpatient Safety Events

Timeframe: Upon discharge from the index hospital admission, up to 30 days

Trial details

NCT IDNCT05666713

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-02-14

Results submitted2026-01-20