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New tool could prevent deadly complication during heart valve procedure

NCT ID NCT05666713

Disease control Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new tool called TELLTALE designed to safely cut a heart tissue flap during a valve replacement procedure (TAVR). In some cases, this flap can block blood flow to the heart, which is often fatal. The trial involved 90 adults at high risk of this complication. Researchers wanted to see if the new device could successfully and safely perform the cutting step, reducing the risk of blocked arteries and other serious problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

90 people

The number who actually took part.

Started

Feb 2023

Finished

Apr 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 109 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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)

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Conditions

The condition(s) this trial relates to.

aortic valve disorder aortic valve insufficiency aortic valve stenosis heart valve disorder Hyperthermia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve failure Valvular heart disease

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • California Pacific Med Ctr

    San Francisco, California, 94109, United States

  • Carilion Medical Center

    Roanoke, Virginia, 24014, United States

  • Emory University

    Atlanta, Georgia, 30308, United States

  • Medstar WHC

    Washington D.C., District of Columbia, 20010, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Rochester Regional Health

    Rochester, New York, 14621, United States

  • St. Francis Hospital and Heart Center

    Roslyn, New York, 11576, United States

  • University of Colorado Health

    Fort Collins, Colorado, 80528, United States

  • University of Washington Heart Institute

    Seattle, Washington, 98195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.