NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
- Conditions
- Aortic Valve FailureValvular Heart Disease
- Interventions
- Device: TELLTALE BASILICA procedure
- Registration Number
- NCT05666713
- Brief 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.
- Detailed Description
Transcatheter aortic valve implantation (TAVR) may cause life threatening coronary artery obstruction, whether implanted in native aortic stenosis or bioprosthetic aortic valve failure.
We have developed and validated the techniques of BASILICA (Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during transcatheter aortic valve replacement), using bedside modification of off-the-shelf guidewires. These bedside modifications require additional assembly steps and special expertise, and thereby risks procedure failure and complications.
Transmural Systems and NHLBI have developed a purpose-built electrosurgical guidewire system (TELLTALE) to simplify the BASILICA-TAVR procedure. The purpose of this protocol is to test the efficacy and safety of this purpose-built guidewire in the setting of BASILICA-TAVR.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 139
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment TELLTALE BASILICA procedure Patients undergoing TAVR with BASILICA using the Transmural TELLTALE guidewire system for bioprosthetic aortic valve failure or native aortic stenosis ( on label TAVR)
- Primary Outcome Measures
Name Time Method The efficacy of the TELLTALE guidewire At exit from the cardiac catheterization laboratory The primary efficacy endpoint is Device (technical) success, assessed upon exit from the cardiac catheterization laboratory, including all of the following:-Successful electrosurgical leaflet traversal using the TELLTALE Guidewire, when attempted; and-Successful electrosurgical leaflet laceration using the TELLTALE Guidewire; and-Successful retrieval of the TELLTALE Guidewire System
Inpatient safety Upon discharge from the index hospital admission -(Freedom from) all-cause mortality-(Freedom from) stroke, both disabling and non-disabling-(Freedom from) acute coronary artery obstruction-(Freedom from) emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device-(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
- Secondary Outcome Measures
Name Time Method 30-day safety 30 days Freedom from MACE (according to VARC-3) at 30 days, including freedom from all of the following:-All-cause mortality-All stroke (disabling and non-disabling)-Bleeding VARC-3 Type 2 or greater (requiring two or more units of transfused blood or hemoglobin drop \>3g/dL)-Major vascular, access- related, or cardiac structural complication (according to VARC-3, which includes coronary obstruction)-Acute kidney injury stage 3 or 4-Moderate or severe aortic regurgitation-New permanent pacemaker due to procedure-related conduction abnormalities-Surgery or intervention related to the TELLTALE device
Trial Locations
- Locations (10)
California Pacific Med Ctr
🇺🇸San Francisco, California, United States
Rochester Regional Health
🇺🇸Rochester, New York, United States
University of Colorado Health
🇺🇸Fort Collins, Colorado, United States
Medstar WHC
🇺🇸Washington, District of Columbia, United States
St. Francis Hospital and Heart Center
🇺🇸Roslyn, New York, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Carilion Medical Center
🇺🇸Roanoke, Virginia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of Washington Heart Institute
🇺🇸Seattle, Washington, United States