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

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.

INCLUSION CRITERIA:In order to be eligible to participate in the study, candidates must meet all of the following criteria:Adults age >= 21 yearsHigh 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 obstructionDeemed likely to suffer coronary artery obstruction from TAVR based on NHLBI Core lab analysis of CT, either ofRisk is narrow Sinus of Valsalva: (a) Leaflet height is greater than coronary artery height, and (b) Virtual transcatheter valve-to-coronary (VTC) distance < 4mmRisk 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 SinusConcurrence of the Study Eligibility CommitteeAble to understand the protocol, consents in writing to participate, and willing to comply with all study procedures for the duration of the studyEXCLUSION CRITERIA:Requires doppio (two-leaflet) BASILICAFlail target leaflet at baselineExcessive target aortic leaflet calcification (no basal calcium-free window or potentially obstructive calcific masses) on baseline CTPlanned provisional (pre-position coronary artery) stents despite BASILICARequires non-femoral accessRequires 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 therapyNot expected to survive for 12 monthsPregnant at the time of intended treatment (day 0)