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Sponsor study identifier
Secondary identifiers
interventional
90
1 country
10
Study Start
February 21, 2023
Actual (reported)Primary Completion
February 14, 2025
Actual (reported)Study Completion
April 25, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 25, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 24, 2022
Actual (reported)December 28, 2022
Actual (reported)February 21, 2023
Actual (reported)February 14, 2025
Actual (reported)April 25, 2025
Actual (reported)February 3, 2026
Actual (reported)Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System
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
1 minute following procedure discharge (Exit from the catheterization laboratory)
Number of Inpatient Safety Events
Inpatient safety as defined by: 1. Freedom from all-cause mortality as defined as the total number of deaths from any cause 2. Freedom from stroke, both disabling and non-disabling * Disabling stroke according to VARC-3 is defined as a stroke resulting in significant, persistent neurological deficits that impact a patient's ability to perform daily activities. * Non-disabling stroke according to VARC-3, involves stroke symptoms that don't significantly impair a patient's ability to perform daily activities or lead to a worsening of their pre-stroke disability level. 3. Freedom from acute coronary artery obstruction 4. Freedom from emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device- 5. Freedom from BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet
Upon discharge from the index hospital admission, up to 30 days
Freedom From Safety Events
Up to Day 30
Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system.
The TELLTALE BASILICA procedure has five steps: (1) engagement of the target leaflet with a guiding catheter; (2) electrosurgical leaflet traversal with the TELLTALE guidewire, (3) preparation and positioning of the TELLTALE guidewire electrosurgical leaflet laceration surface; (4) electrosurgical leaflet laceration with the TELLTALE guidewire, immediately followed by (5) TAVR. These are all guided by fluoroscopy, with adjunctive echocardiography as needed.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
California Pacific Med Ctr
San Francisco, California, 94109, United States
University of Colorado Health
Fort Collins, Colorado, 80528, United States
Medstar WHC
Washington D.C., District of Columbia, 20010, United States
Emory University
Atlanta, Georgia, 30308, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Rochester Regional Health
Rochester, New York, 14621, United States
St. Francis Hospital and Heart Center
Roslyn, New York, 11576, United States
Robert J Lederman, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
90 participants (actual enrollment reported by the registry).
First Submitted
December 24, 2022
First Posted
December 28, 2022
Study Start
February 21, 2023
Actual (reported)Contact the study team to confirm eligibility.
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carilion Medical Center
Roanoke, Virginia, 24014, United States
University of Washington Heart Institute
Seattle, Washington, 98195, United States
Primary Completion
February 14, 2025
Actual (reported)Study Completion
April 25, 2025
Actual (reported)Last Updated
February 3, 2026
Results First Posted
February 3, 2026
Record last verified: 2026-01
Deidentified individual participant results data will be made available 6 months after publication date for a period of 5 year by sending a request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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