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One procedure to fix rhythm and block clots: new study tests dual approach for AFib

NCT ID NCT07523620

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Updated 2 times

Summary

This study tests doing two procedures at once for people with atrial fibrillation (AFib): a catheter ablation to restore normal heart rhythm and a device implant to close off a part of the heart where clots form. The goal is to see if this combined approach is safe and effective at controlling AFib and reducing stroke risk. About 240 adults with AFib and a high stroke risk will take part, and they will stop blood thinners about 3 months after 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.

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 240 people

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

Started

Mar 2026

Expected to finish

Feb 2028

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: * Subject must provide written informed consent prior to any clinical investigation-related procedure. * 18 years of age or older, or the age of legal consent * CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men * Able to stop anticoagulation by 90 days post index procedure * Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT * Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF * Documented symptomatic PAF or PersAF. Documentation requirements are as follows: Paroxysmal: * Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND * One electrocardiographically documented PAF episode within 12 months prior to enrollment. Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by * Physician's note, AND either * 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR * Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF: * That are taken at least 7 days apart but less than 12 months apart * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment * The most recent electrocardiogram must be within 180 days of enrollment. NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device. Exclusion Criteria: * Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure * Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention) * Patients with heart prosthetic valves * Patient implanted with an inferior vena cava filter * Patients with left ventricular ejection fraction ≤30% * Patients with NYHA Class IV heart failure * Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope) * Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure * Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device) * Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration) * Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure * Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation * Patients with a stent, constriction, or stenosis in a pulmonary vein * Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2) * Patients with severe renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2) or on chronic dialysis * Patients with severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF) Paroxysmal af Persistent atrial fibrillation

How to take part

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

  1. The places running it

    16 sites in 10 countries. 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

  • ASST Grande Ospedale Metropolitano

    RECRUITING

    Milan, Lombard, 20162, Italy

  • Cardioangiologisches Centrum am Bethanien Krankenhaus

    RECRUITING

    Frankfurt am Main, Hesse, 60389, Germany

  • Centralny Szpital Kliniczny Uniwersytetu

    NOT_YET_RECRUITING

    Lodz, Poland

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, Italy, 20138, Italy

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Deutsches Herzzentrum der Charite

    RECRUITING

    Berlin, State of Berlin, 13353, Germany

  • Hospital de la Santa Creu I Sant Pau

    RECRUITING

    Barcelona, Catalon, 08025, Spain

  • John Radcliffe Hospital

    NOT_YET_RECRUITING

    Oxford, United Kingdom

  • Mater Private Hospital

    RECRUITING

    Dublin, Dublin, Dublin 7, Ireland

  • Motol and Homolka University Hospital

    RECRUITING

    Prague, Czech Republic, 1500, Czechia

  • Rigshospitalet

    RECRUITING

    Copenhagen, Copenha, 2100, Denmark

  • Royal Sussex County Hospital

    NOT_YET_RECRUITING

    Brighton, United Kingdom

  • Slaskie Centrum Chorob Serca

    NOT_YET_RECRUITING

    Zabrze, Silesian Voivodeship, 41-800, Poland

  • UZ Brussel

    RECRUITING

    Brussels, B CAP R, 1090, Belgium

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    RECRUITING

    Lübeck, Schlesw, 23538, Germany

  • Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, Dzukija, 08406, Lithuania

More trials for these conditions

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