Back to resultsNHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Primary Purpose
Valvular Heart Disease, Aortic Valve Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TELLTALE BASILICA procedure
Sponsored by
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
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Patients undergoing TAVR with BASILICA using the Transmural TELLTALE guidewire system for bioprosthetic aortic valve failure or native aortic stenosis ( on label TAVR)
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05666713
First Posted
December 24, 2022
Last Updated
September 8, 2023
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05666713
Brief Title
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
2. Study Status
Record Verification Date
August 30, 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients undergoing TAVR with BASILICA using the Transmural TELLTALE guidewire system for bioprosthetic aortic valve failure or native aortic stenosis ( on label TAVR)
Intervention Type
Device
Intervention Name(s)
TELLTALE BASILICA procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
The efficacy of the TELLTALE guidewire
Description
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
Time Frame
At exit from the cardiac catheterization laboratory
Title
Inpatient safety
Description
-(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
Time Frame
Upon discharge from the index hospital admission
Secondary Outcome Measure Information:
Title
30-day safety
Description
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
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
109 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annette Stine, R.N.
Phone
(301) 402-5558
Email
stinea@nhlbi.nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Robert J Lederman, M.D.
Phone
(301) 402-6769
Email
lederman@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Lederman, M.D.
Organizational Affiliation
National Heart, Lung, and Blood Institute (NHLBI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Pacific Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonnie Chan
Phone
650-696-5002
Email
chanbw@sutterhealth.org
Facility Name
University of Colorado Health
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Dilorenzo
Phone
303-520-5434
Email
maria.dilorenzo@uchealth.org
Facility Name
Medstar WHC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassandra Lopez
Phone
202-877-2452
Email
Kassandra.Lopez@medstar.net
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuxun (Tracy) Xu
Phone
404-686-7667
Email
chuxun.xu@emory.edu
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenifer Kaufman
Phone
617-632-8956
Email
jmkaufma@bidmc.harvard.edu
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Booth
Phone
718-920-6523
Email
kbooth@montefiore.org
Facility Name
Rochester Regional Health
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer LaLonde, RN
Phone
585-922-3536
Email
Jennifer.LaLonde@RochesterRegional.org
Facility Name
St. Francis Hospital and Heart Center
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Haag
Phone
516-622-4512
Email
elizabeth.haag@chsli.org
Facility Name
Sentara Norfolk General Hospital, Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer May, PhD, CCRP
Phone
757-388-1926
Email
jlfreema@sentara.com
Facility Name
University of Washington Heart Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Schaeffer
Phone
206-221-9154
Email
jschaeffer@cardiology.washington.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
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