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

NAActive, not recruitingINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

February 27, 2023

Primary Completion Date

February 14, 2025

Study Completion Date

May 14, 2025

Conditions
Valvular Heart DiseaseAortic Valve Failure
Interventions
DEVICE

TELLTALE BASILICA procedure

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.

Trial Locations (10)

10467

Montefiore Medical Center, The Bronx

11576

St. Francis Hospital and Heart Center, Roslyn

14621

Rochester Regional Health, Rochester

20010

Medstar WHC, Washington D.C.

24014

Carilion Medical Center, Roanoke

30308

Emory University, Atlanta

80528

University of Colorado Health, Fort Collins

94109

California Pacific Med Ctr, San Francisco

98195

University of Washington Heart Institute, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH