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Can a tiny clip seal a heart pouch and prevent strokes?

NCT ID NCT07742839

Disease control Sponsor: Edwards Lifesciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study is testing a device called the ECLIPTIS clip, which is placed during open-heart surgery to close off the left atrial appendage—a small pouch in the heart where blood can pool and form clots that may cause strokes. The trial will enroll about 168 adults who are already scheduled for heart surgery and will check how well the clip seals the pouch and whether it causes any major complications within 30 days. The goal is to see if this clip is a safe and effective way to reduce stroke risk in people with heart conditions.

What this could mean

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

Active substance
Edwards ECLIPTIS Left Atrial Appendage Exclusion System (a surgical clip)
What this could lead to
If successful, this could provide a safe and effective way to close the left atrial appendage during heart surgery, potentially reducing the risk of stroke in patients with atrial fibrillation.
What could go wrong
This is an observational study, so it doesn't compare the clip to other treatments. The results depend on the skill of surgeons and may not apply to all patients. There are risks of bleeding, infection, or other complications from the procedure.

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.

Participants

About 168 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

Aug 2030

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.

Who is studied

The target population includes adult candidates who require exclusion of their left atrial appendage via a surgical clip while undergoing a concomitant cardiac surgical procedure.

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: * ≥18 years old * Willing and able to provide consent and comply with study follow-up requirements * Scheduled to undergo concomitant open-heart cardiac surgery with planned implantation of ECLIPTIS clip for LAA exclusion per IFU Exclusion Criteria: * Known life expectancy \<1 year * Previous cardiac surgery (re-operation) * Prior LAA isolation attempts * Planned right thoracotomy approach * Concomitant open-heart surgery that is considered an emergency * Thrombus in left atrium/LAA that cannot be evacuated before placement of clip * Based on intraoperative evaluation, LAA is not appropriate for exclusion prior to positioning ECLIPTIS clip to the base of the LAA

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As listed by the trial registrant

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

Atrial appendage

How to take part

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  1. 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 ↗

  2. A doctor treating you

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