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.
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.
Brief Title
NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Valvular Heart Disease
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, any 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)
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, any 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)
Inclusion 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, any 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
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, any 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
Gender
All
Gender Based
false
Keywords
Structural heart disease interventions
TAVR
TAVR Associated Coronary Artery Obstruction
Electrosurgery
Native Aortic Valve Failure
Bioprosthetic Aortic Valve Failure
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
109 Years
Minimum Age
21 Years
NCT Id
NCT05666713
Org Class
Nih
Org Full Name
National Institutes of Health Clinical Center (CC)
Org Study Id
10000673
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
NHLBI Transmural Electrosurgery LeafLet Traversal and Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
Primary Outcomes
Outcome 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
Outcome Measure
The efficacy of the TELLTALE guidewire
Outcome Time Frame
At exit from the cardiac catheterization laboratory
Outcome 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
Outcome Measure
Inpatient safety
Outcome Time Frame
Upon discharge from the index hospital admission
Secondary Ids
Secondary Id
000673-H
Secondary Outcomes
Outcome 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
Outcome Time Frame
30 days
Outcome Measure
30-day safety
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
109
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076