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Can a catheter slice thick heart muscle without open surgery?

NCT ID NCT07806149

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study tests a minimally invasive procedure called SESAME for people with thickened heart muscle that blocks blood flow from the heart. The procedure uses a catheter to make a controlled slice in the muscle, aiming to relieve symptoms like shortness of breath. Researchers will enroll about 200 adults who have hypertrophic cardiomyopathy or who are at risk of blockage during valve replacement. The main goals are to see if the procedure works as planned and if it is safe within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SESAME procedure, a catheter-based technique that uses guidewires and an electrosurgery timing device to create a controlled slice through thickened heart muscle, without open surgery.
What this could lead to
If successful, this could offer a less invasive alternative to open-heart surgery for people with thickened heart muscle that blocks blood flow, potentially delaying or avoiding the need for valve replacement.
What could go wrong
This is an early study with a small number of participants. The procedure carries risks such as bleeding, heart rhythm problems, or damage to heart structures, and it may not work for everyone.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

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 100 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 * Adults age \>= 21 years * Requires left ventricular septal reduction therapy for one of two indications 1. Obstructive hypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction (30mmHg peak while resting OR 50mmHg peak when provoked); OR 2. Planned transcatheter mitral valve replacement is feasible but limited by risk for iatrogenic left ventricular outflow tract obstruction, defined on contrast-enhanced CT as skirt-neo-LVOT \<200\^2 * Planning to undergo SESAME transcatheter myotomy * Septal diastolic thickness on CT as measured by the NHLBI central laboratory before enrollment: * For obstructive hypertrophic cardiomyopathy, \>=14mm; * For transcatheter heart valve replacement, \>=12mm and * Intended minimum diastolic residual septal thickness \>=6mm -Severely symptomatic, any of * NYHA Class III or greater * Canadian Angina Class CCS III or greater * Explicitly chooses investigational SESAME over conventional treatment approaches including 1. cardiac myosin inhibitor therapy, if eligible (obstructive HCM only); 2. transcoronary alcohol septal ablation, if eligible; or 3. surgical left ventricular myotomy and/or myectomy, if eligible * Concurrence of the multidisciplinary institutional heart team that the candidate is at high risk for surgical myectomy and that SESAME is an appropriate septal reduction strategy for this candidate. * Willing to return for all scheduled follow-up activities, and eligible or able to undergo required protocol and testing EXCLUSION CRITERIA * Does not consent to participate, or unable to consent to participate * Pregnant * Hemodynamic instability or emergency procedure * Mechanical aortic valve * eGFR \< 30 mL/min/1.73m\^2

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy Ventricular Outflow Obstruction, Left

As listed by the trial registrant

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

Hypertrophic cardiomyopathy Left ventricular outflow obstruction Systolic anterior motion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • MedStar Washington Hospital Center

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

  • Montefiore Medical Center: Einstein Campus

    The Bronx, New York, 10461, United States

  • National Heart, Lung and Blood Institute (NHLBI)

    Bethesda, Maryland, 20892, United States

  • St. Francis Hospital &amp; Heart Center

    Roslyn, New York, 11576, United States

  • Univ. of Virginia

    Charlottesville, Virginia, 22908, United States

  • WellSpan York Hospital

    York, Pennsylvania, 17403, United States

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