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

NCT05666713 | Completed Results FDA Device

• 2 other identifiers: 10000673000673-H
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

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.

Conditions

Valvular Heart Disease; Aortic Valve Failure

Keywords

Structural heart disease interventions; TAVR; TAVR Associated Coronary Artery Obstruction; Electrosurgery; Native Aortic Valve Failure; Bioprosthetic Aortic Valve Failure

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Freedom From Safety Events

  Up to Day 30

Study Arms (1)

Participants undergoing TAVR with BASILICA using Transmural TELLTALE guidewire system

EXPERIMENTAL

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.

Device: TELLTALE BASILICA procedure

Interventions

TELLTALE BASILICA procedure DEVICE

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.

Also known as: Transmural TELLTALE guidewire system

Participants undergoing TAVR with BASILICA using Transmural TELLTALE guidewire system

Eligibility Criteria

• Age: 21 Years - 109 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (10)

California Pacific Med Ctr

San Francisco, California, 94109, United States

Location

University of Colorado Health

Fort Collins, Colorado, 80528, United States

Location

Medstar WHC

Washington D.C., District of Columbia, 20010, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Rochester Regional Health

Rochester, New York, 14621, United States

Location

St. Francis Hospital and Heart Center

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

University of Washington Heart Institute

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Heart Valve Diseases; Hyperthermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Results Point of Contact

• Title: Robert Lederman, M.D.
• Organization: National Heart Lung and Blood Institute

lederman@nih.gov

301.402.6769

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: December 28, 2022
• Study Start: February 21, 2023
• Primary Completion: February 14, 2025
• Study Completion: April 25, 2025
• Last Updated: February 3, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be made available 6 months after publication date for a period of 5 year
• Access Criteria: Sending request to Robert.Lederman@nih.gov

Locations

US (10)