NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Valvular Heart Disease, Aortic Valve Failure
About this trial
This is an interventional treatment trial for Valvular Heart Disease focused on measuring Structural heart disease interventions, TAVR, TAVR Associated Coronary Artery Obstruction, Electrosurgery, Native Aortic Valve Failure, Bioprosthetic Aortic Valve Failure
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, either 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)
Sites / Locations
- California Pacific Med Ctr
- University of Colorado Health
- Medstar WHCRecruiting
- Emory University
- Beth Israel Deaconess Medical Center
- Montefiore Medical Center
- Rochester Regional Health
- St. Francis Hospital and Heart CenterRecruiting
- Sentara Norfolk General Hospital, Sentara Cardiovascular Research Institute
- University of Washington Heart Institute
Arms of the Study
Arm 1
Experimental
Treatment
Patients undergoing TAVR with BASILICA using the Transmural TELLTALE guidewire system for bioprosthetic aortic valve failure or native aortic stenosis ( on label TAVR)