Clinical trial NCT05666713: NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Official title: NHLBI Transmural Electrosurgery LeafLet Traversal and Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2022-12-28
Enrollment: 139
Sex: ALL
Minimum age (years): 21
Maximum age (years): 109
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: * 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 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

EXCLUSION CRITERIA:

* 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)

Primary outcomes:
measure: The efficacy of the TELLTALE guidewire
timeFrame: At exit from the cardiac catheterization laboratory
measure: Inpatient safety
timeFrame: Upon discharge from the index hospital admission
Secondary outcomes:
measure: 30-day safety
timeFrame: 30 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Med Ctr
state: California
city: Fort Collins
country: United States
facility: University of Colorado Health
state: Colorado
city: Washington
country: United States
facility: Medstar WHC
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester Regional Health
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital and Heart Center
state: New York
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington Heart Institute
state: Washington
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Robert J Lederman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: