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

Last updated: April 4, 2025
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiac Disease

Heart Valve Disease

Cardiovascular Disease

Treatment

TELLTALE BASILICA procedure

Clinical Study ID

NCT05666713
10000673
000673-H
  • Ages 21-109
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  • 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 localmultidisciplinary 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 ofTAVR-induced coronary artery obstruction

  • Deemed likely to suffer coronary artery obstruction from TAVR based on NHLBI Corelab analysis of CT, any of

  • Risk is narrow Sinus of Valsalva: (a) Leaflet height is greater than coronaryartery height, and (b) Virtual transcatheter valve-to-coronary (VTC) distance < 4mm

  • Risk is Sinus sequestration: (a) Threatening leaflet height is greater thansinotubular junction, and (b) Virtual transcathetervalve-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 tocomply with all study procedures for the duration of the study

Exclusion

EXCLUSION CRITERIA:

  • Requires doppio (two-leaflet) BASILICA

  • Flail target leaflet at baseline

  • Excessive target aortic leaflet calcification (no basal calcium-free window orpotentially 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 coronaryintervention for baseline obstructive coronary artery disease)

  • Chronic kidney disease KDIGO stage 4 or 5 (eGFR < 29 ml/min/1.73m2) or renalreplacement therapy

  • Not expected to survive for 12 months

  • Pregnant at the time of intended treatment (day 0)

Study Design

Total Participants: 139
Treatment Group(s): 1
Primary Treatment: TELLTALE BASILICA procedure
Phase:
Study Start date:
February 27, 2023
Estimated Completion Date:
May 14, 2025

Study 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.

Connect with a study center

  • California Pacific Med Ctr

    San Francisco, California 94109
    United States

    Site Not Available

  • University of Colorado Health

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Medstar WHC

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Rochester Regional Health

    Rochester, New York 14621
    United States

    Site Not Available

  • St. Francis Hospital and Heart Center

    Roslyn, New York 11576
    United States

    Site Not Available

  • Sentara Norfolk General Hospital, Sentara Cardiovascular Research Institute

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Carilion Medical Center

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • University of Washington Heart Institute

    Seattle, Washington 98195
    United States

    Site Not Available

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