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

Completed · Not applicable

Conditions studied: Valvular Heart Disease, Aortic Valve Failure

In brief

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.

Key facts

Study ID

NCT05666713

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

90

Starts

2023-02-21

Expected to finish

2025-04-25

Last updated by the study team

2026-02-03

Who can join

Age: 21 and older, up to 109. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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-femoral access
• Requires concomitant procedures during TAVR (such as percutaneous coronary intervention for baseline obstructive coronary artery disease)
• Chronic kidney disease KDIGO stage 4 or 5 (eGFR < 29 ml/min/1.73m2) or renal replacement therapy
• Not expected to survive for 12 months
• Pregnant at the time of intended treatment (day 0)

Where it is running

• California Pacific Med Ctr — San Francisco, California, United States
• University of Colorado Health — Fort Collins, Colorado, United States
• Medstar WHC — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Rochester Regional Health — Rochester, New York, United States
• St. Francis Hospital and Heart Center — Roslyn, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carilion Medical Center — Roanoke, Virginia, United States
• University of Washington Heart Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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