Valvular Heart DiseaseNCT05666713
NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
A study testing TELLTALE BASILICA procedure in people with Valvular Heart Disease and Aortic Valve Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 109 years
- Conditions the study is for
- Valvular Heart Disease, Aortic Valve Failure
- What is being tested?
- TELLTALE BASILICA procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesUnited States
- Study dates
- 21 Feb 2023to 25 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 109 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University
Atlanta, Georgia, 30308
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Colorado Health
Fort Collins, Colorado, 80528
Carilion Medical Center
Roanoke, Virginia, 24014
Rochester Regional Health
Rochester, New York, 14621
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
California Pacific Med Ctr
San Francisco, California, 94109
University of Washington Heart Institute
Seattle, Washington, 98195
Montefiore Medical Center
The Bronx, New York, 10467
Medstar WHC
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Valvular Heart Disease, Aortic Valve Failure
- Being tested
- TELLTALE BASILICA procedure
- Keywords
- Structural heart disease interventions, TAVR, TAVR Associated Coronary Artery Obstruction, Electrosurgery, Native Aortic Valve Failure, Bioprosthetic Aortic Valve Failure
- Medical subject headings
- Heart Valve Diseases, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELLTALE BASILICA procedureDevice
Also called Transmural TELLTALE guidewire system
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing TAVR with BASILICA using Transmural TELLTALE guidewire system | Experimental | Participants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system. Receives: Device: TELLTALE BASILICA procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System
The primary efficacy endpoint is technical success, which is defined when the following criteria are all met:
- Successful electrosurgical leaflet traversal using the TELLTALE Guidewire
- Successful electrosurgical leaflet laceration using the TELLTALE Guidewire
- Successful retrieval of the TELLTALE Guidewire System
Measured: 1 minute following procedure discharge (Exit from the catheterization laboratory)
Number of Inpatient Safety Events
Inpatient safety as defined by:
- Freedom from all-cause mortality as defined as the total number of deaths from any cause
- Freedom from stroke, both disabling and non-disabling
- Disabling stroke according to VARC-3 is defined as a stroke resulting in significant, persistent neurological deficits that impact a patient's ability to perform daily activities.
- Non-disabling stroke according to VARC-3, involves stroke symptoms that don't significantly impair a patient's ability to perform daily activities or lead to a worsening of their pre-stroke disability level.
- 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
Measured: Upon discharge from the index hospital admission, up to 30 days
Secondary outcomes (1)
Freedom From Safety Events
30-day safety as assessed by freedom from
- Major Adverse Cardiovascular Events defined by no periprocedural myocardial infarction, cerebrovascular events, and periprocedural all-cause mortality
- All-cause mortality: defined as total number of deaths from any cause
- All stroke (disabling and non-disabling per VARC-3)
- Disabling results in significant, persistent neurological deficits that impact daily activities
- Non-disabling involves stroke symptoms that don't significantly impair daily activities or lead to worsening of their pre-stroke level
- 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, including 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
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start21 Feb 2023
- Primary completion14 Feb 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666713
- Sponsor's protocol ID
- 10000673
- Other IDs
- 000673-H
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2022
- Last updated
- 3 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual participant results data will be made available 6 months after publication date for a period of 5 year by sending a request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHLBI Transmural Electrosurgery LeafLet Traversal and Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial
- ClinicalTrials.gov ID
- NCT05666713
- Acronym / sponsor ID
- 10000673
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Posted 3 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing TAVR with BASILICA using Transmural TELLTALE guidewire system | Experimental | Device: TELLTALE BASILICA procedureParticipants with severe aortic stenosis or failure of surgically-implanted bioprosthetic valve undergoing transcatheter aortic valve replacement (TAVR) with bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) using the Transmural TELLTALE guidewire system. |
Who may qualify
- Ages
- 21 to 109 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TELLTALE BASILICA procedureAlso: Transmural TELLTALE guidewire systemThe 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. | Device | Participants undergoing TAVR with BASILICA using Transmural TELLTALE guidewire system |
Primary outcome
Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System
Time frame: 1 minute following procedure discharge (Exit from the catheterization laboratory)
The primary efficacy endpoint is technical success, which is defined when the following criteria are all met: 1. Successful electrosurgical leaflet traversal using the TELLTALE Guidewire 2. Successful electrosurgical leaflet laceration using the TELLTALE Guidewire 3. Successful retrieval of the TELLTALE Guidewire System
Number of Inpatient Safety Events
Time frame: Upon discharge from the index hospital admission, up to 30 days
Inpatient safety as defined by: 1. Freedom from all-cause mortality as defined as the total number of deaths from any cause 2. Freedom from stroke, both disabling and non-disabling * Disabling stroke according to VARC-3 is defined as a stroke resulting in significant, persistent neurological deficits that impact a patient's ability to perform daily activities. * Non-disabling stroke according to VARC-3, involves stroke symptoms that don't significantly impair a patient's ability to perform daily activities or lead to a worsening of their pre-stroke disability level. 3. Freedom from acute coronary artery obstruction 4. Freedom from emergency cardiac surgery or reintervention related to the TELLTALE BASILICA procedure or device- 5. 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
1 secondary outcome
Freedom From Safety Events
Time frame: Up to Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified individual participant results data will be made available 6 months after publication date for a period of 5 year by sending a request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TELLTALE BASILICA procedure in people with Valvular Heart Disease and Aortic Valve Failure, run by National Heart, Lung, and Blood Institute (NHLBI) at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System (time frame: 1 minute following procedure discharge (Exit from the catheterization laboratory)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.