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

Study Overview
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Brief Summary
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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
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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.

Official Title
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NHLBI Transmural Electrosurgery LeafLet Traversal and Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

Conditions
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Valvular Heart Disease, Aortic Valve Failure

Intervention / Treatment
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* Device: TELLTALE BASILICA procedure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 109 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients undergoing TAVR with BASILICA using the Transmural TELLTALE guidewire system for bioprosthetic aortic valve failure or native aortic stenosis ( on label TAVR) | Device: TELLTALE BASILICA procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of the TELLTALE guidewire | The primary efficacy endpoint is Device (technical) success, assessed upon exit from the cardiac catheterization laboratory, including all of the following:-Successful electrosurgical leaflet traversal using the TELLTALE Guidewire, when attempted; and-Successful electrosurgical leaflet laceration using the TELLTALE Guidewire; and-Successful retrieval of the TELLTALE Guidewire System | At exit from the cardiac catheterization laboratory | 
| Inpatient safety | -(Freedom from) all-cause mortality-(Freedom from) stroke, both disabling and non-disabling-(Freedom from) acute coronary artery obstruction-(Freedom from) emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device-(Freedom from) BASILICA-related complications including coronary artery perforation, coronary artery dissection, aortic dissection, cardiac free wall perforation, or systemic embolization of a native or bioprosthetic leaflet | Upon discharge from the index hospital admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day safety | Freedom from MACE (according to VARC-3) at 30 days, including freedom from all of the following:-All-cause mortality-All stroke (disabling and non-disabling)-Bleeding VARC-3 Type 2 or greater (requiring two or more units of transfused blood or hemoglobin drop >3g/dL)-Major vascular, access- related, or cardiac structural complication (according to VARC-3, which includes coronary obstruction)-Acute kidney injury stage 3 or 4-Moderate or severe aortic regurgitation-New permanent pacemaker due to procedure-related conduction abnormalities-Surgery or intervention related to the TELLTALE device | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Structural heart disease interventions, TAVR, TAVR Associated Coronary Artery Obstruction, Electrosurgery, Native Aortic Valve Failure, Bioprosthetic Aortic Valve Failure