Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental heart slicing procedure tested on one patient

NCT ID NCT06269640

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 early study tested a new procedure called SESAME that uses a wire threaded through blood vessels to slice away excess heart muscle in people with hypertrophic cardiomyopathy. Only one adult participated before the study was terminated. The goal was to see if the technique could safely reduce blockage of blood flow from the heart.

What this could mean

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

Active substance
Septal Scoring Along Midline Endocardium (SESAME) device
What this could lead to
If refined, this could offer a less invasive alternative to open-heart surgery for reducing thickened heart muscle and improving blood flow.
What could go wrong
This was a very early feasibility study with only 1 participant and was terminated. The procedure carries serious risks like stroke, heart damage, or need for a pacemaker.

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

1 person

The number who actually took part.

Started

Dec 2024

Finished

Dec 2024

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 99 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 debulking of left ventricular septum for hypertrophic cardiomyopathy * Septal diastolic thickness of obstructive hump on CT: * Total \>=16 mm, and * Predicted residual septal thickness \>= 8 mm, and * Predicted laceration depth \>= 6 mm * 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; (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 * Concurrence of the study Central Clinical Eligibility Committee * 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 * Requires antegrade SESAME access (because of mechanical aortic valve) * Prior completed transcoronary alcohol septal ablation, or prior surgical myectomy * Pregnant * Hemodynamic instability or emergency procedure * eGFR \< 30 mL/min/1.73m\^2 * Survival despite successful procedure expected \< 12months

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve stenosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

aortic valve stenosis hypertrophic cardiomyopathy mitral valve disorder

As listed by the trial registrant

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

Aortic valve stenosis Hypertrophic cardiomyopathy Left ventricular septal hypertrophy Mitral valve disease

Contacts and locations

Locations

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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