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Heart clip aims to cut stroke risk in surgery patients

NCT ID NCT06203054

Disease control Sponsor: Medtronic Cardiac Surgery Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called Penditure that clips shut the left atrial appendage, a small pouch in the heart, during other heart surgeries. The goal is to prevent blood clots from forming there and causing strokes. About 198 adults having heart surgery will be enrolled, and doctors will check if the clip works well and is safe.

What this could mean

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

Active substance
Penditure™ Left Atrial Appendage Exclusion System (a clip device)
What this could lead to
If successful, this device could provide a safe and effective way to close the left atrial appendage during heart surgery, potentially lowering stroke risk.
What could go wrong
This is a post-market study, not a randomized trial, so results may not prove superiority over other methods. Device-related complications or incomplete closure are possible.

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

198 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Patient is indicated to be treated with the Penditure™ left atrial appendage (LAA) Exclusion System * Greater than or equal to 18 years of age * The subject is willing and able to provide written informed consent and comply with study visit requirements Exclusion Criteria: * Prior left atrial appendage (LAA) isolation attempt(s) * Need for emergent cardiac surgery * Subject is contraindicated for multi-detector computed tomography (MDCT) and/or transesophageal echocardiogram (TEE) * Life expectancy of less than 12 months * History of cardiac surgery * Pericarditis * Presence of thrombus in the left atrium or left atrial appendage (LAA), prior to or during the procedure * Patients requiring a heart transplant, insertion of a ventricular assist device or total artificial heart, and/or ascending aortic aneurysm or dissection repair requiring circulatory arrest * Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score greater than 4 or subject deemed to be high or extreme risk per surgeon assessment * Ejection fraction less than 30% * Chronic Kidney Disease Stage IV or V (estimated glomerular filtration rate (eGFR) \<30 ml/min) * New York Heart Association (NYHA) Class IV heart failure symptoms * Patient has a documented history of substance (drug or alcohol) abuse * Known allergy to device components (Nickel and/or Titanium) * In the opinion of the investigator, the subject is not a suitable candidate for LAA isolation due to risks outweighing potential benefits including, complexity of planned concomitant procedures, or other pre-existing medical conditions * Currently participating in an investigational drug or another device trial or study (excluding registries)

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As listed by the trial registrant

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

Left atrial appendage exclusion

Contacts and locations

Locations

  • Ascension St. Vincent Heart Center

    Carmel, Indiana, 46290, United States

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096, United States

  • Mayo Clinic Saint Marys Campus

    Rochester, Minnesota, 55905, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • Saint Joseph's Hospital Health Center

    Syracuse, New York, 13203, United States

  • Swedish Medical Center Cherry Hill

    Seattle, Washington, 98112, United States

  • UPMC Pinnacle Harrisburg Campus

    Harrisburg, Pennsylvania, 17101, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States