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New heart device aims to cut stroke risk without Long-Term blood thinners

NCT ID NCT05147792

Disease control Sponsor: Conformal Medical, Inc 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 6 times

Summary

This study tests a new device called CLAAS that is placed in the heart to prevent strokes in people with atrial fibrillation (an irregular heartbeat). About 1600 participants will be randomly assigned to get either the new device or one of two already-approved devices. The goal is to see if the new device is as safe and effective at preventing strokes and blood clots, while reducing the need for long-term blood thinner medication.

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 1,600 people

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

Started

May 2022

Expected to finish

Dec 2031

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: 1. Male or non-pregnant female aged ≥18 years 2. Documented non-valvular AF (paroxysmal, persistent, or permanent) 3. High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3 4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation 5. Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy. 6. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care 7. Able to comply with the protocol-specified medication regimen and follow-up evaluations 8. The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC). Exclusion Criteria: 1. Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure. 2. Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure) 3. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) 4. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve) 5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated 6. Documented active systemic infection 7. Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment 8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure 9. Recent (within 30 days of index procedure) stroke or transient ischemic attack 10. Recent (within 30 days of index procedure) myocardial infarction 11. Vascular access precluding delivery of implant with catheter-based system 12. Severe heart failure (New York Heart Association Class IV) 13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant 14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation) 15. Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3 16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or to device materials (e.g., nickel, titanium), or the subject has contrast sensitivity that cannot be adequately pre-medicated 17. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial 18. Unable to undergo general anesthesia 19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years 20. A condition which precludes adequate transesophageal echocardiographic assessment Echo exclusion criteria: 1. Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial) 2. Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE 3. Left ventricular ejection fraction (LVEF) \<30% 4. Moderate or large pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology 5. Atrial septal defect that warrants closure 6. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \> 15 mm) or large shunt (early \[within 3 beats\] and/or substantial passage of bubbles, e.g., \>20) 7. Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2) 8. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch 9. Evidence of cardiac tumor

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation Stroke

How to take part

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

  1. The places running it

    93 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • AKFA Medline

    Olmazor, Tashkent, 100211, Uzbekistan

  • Abrazo Arizona Heart Hospital

    Phoenix, Arizona, 85016, United States

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • AdventHealth Tampa

    Tampa, Florida, 33613, United States

  • Albany Medical Center / Capital Cardiology Associates

    Albany, New York, 12208, United States

  • Arizona Heart Arrhythmia Associates

    Phoenix, Arizona, 85018, United States

  • Ascension St. Vincent - Carmel, IN

    Indianapolis, Indiana, 46260, United States

  • Ascension St. Vincent's Jacksonville

    Jacksonville, Florida, 32204, United States

  • Asklepios Klinik-Altona

    Hamburg, 22763, Germany

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Baptist Health Care - Pensacola

    Pensacola, Florida, 32503, United States

  • Baptist Hospital of Miami

    Miami, Florida, 33176, United States

  • Baylor Scott & White Research Institute

    Plano, Texas, 75093, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Bellin Health

    Green Bay, Wisconsin, 54301, United States

  • CHI Health / CommonSpirit Research Institute

    Omaha, Nebraska, 68124, United States

  • CHRISTUS Health

    Tyler, Texas, 75701, United States

  • CHU La Timone, Marseille

    Marseille, 13005, France

  • CHU de Bordeaux

    Bordeaux, 33604, France

  • CHU de Toulouse

    Toulouse, 31059, France

  • Cardiovasculäres Centrum Frankfurt

    Frankfurt, 60389, Germany

  • Carilion Clinic

    Roanoke, Virginia, 24014, United States

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303, United States

  • Chapidze Heart Disease Center

    Tbilisi, Georgia

  • Chippenham Hospital

    Richmond, Virginia, 23225, United States

  • Clinique Pasteur, Toulouse

    Toulouse, 31076, France

  • Community Memorial Hospital Ventura

    Ventura, California, 93003, United States

  • Cooper University - Heart House

    Haddon Heights, New Jersey, 08104, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Deborah Heart and Lung

    Browns Mills, New Jersey, 08015, United States

  • Elisabeth Krankenhaus

    Essen, 45138, Germany

  • Emory University

    Atlanta, Georgia, 30342, United States

  • Erlanger Health System

    Chattanooga, Tennessee, 37403, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • HCA Grand Strand

    Myrtle Beach, South Carolina, 29572, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hartford Health Care St. Vincent's Medical Center

    Bridgeport, Connecticut, 06606, United States

  • Henry Ford Providence Southfield Hospital

    Southfield, Michigan, 48075, United States

  • Henry Ford St. John Hospital

    Detroit, Michigan, 48236, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Huntington Hospital

    Pasadena, California, 91105, United States

  • Institut Cardiovasculaire Paris Sud

    Massy, 91300, France

  • Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, Georgia

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Kansas City Cardiac Arrhythmia Research, LLC

    Overland, Missouri, 66211, United States

  • Lahey Hospital & Medical Centeer

    Burlington, Massachusetts, 01805, United States

  • Lankenau Heart Institute

    Wynnewood, Pennsylvania, 19096, United States

  • Largo Medical Center

    Largo, Florida, 33770, United States

  • Lexington Medical Center

    West Columbia, South Carolina, 29169, United States

  • Lifespan Health System

    Providence, Rhode Island, 02903, United States

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

  • M Health Fairview St. John's Hospital

    Maplewood, Minnesota, 55109, United States

  • MedStar Washington Hospital Center

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

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77094, United States

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540, United States

  • Mission Hospital

    Asheville, North Carolina, 28801, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Nemocnice Na Homolce

    Prague, 150 00, Czechia

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Northside Hospital, Inc

    Atlanta, Georgia, 30342, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Pacific Heart Institute

    Santa Monica, California, 90405, United States

  • Piedmont Health Institute

    Atlanta, Georgia, 30309, United States

  • Pima Heart & Vascular

    Tucson, Arizona, 85719, United States

  • Prisma Health

    Columbia, South Carolina, 29203, United States

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • Republican Specialized Center for Surgery named after V. Vakhidov

    Chilanzar, Tashkent, 100115, Uzbekistan

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239, United States

  • Sentara Norfolk

    Norfolk, Virginia, 23507, United States

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120, United States

  • St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401, United States

  • Tbilisi Heart Center

    Tbilisi, Georgia

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, Georgia

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee, 37934, United States

  • Terrebone - Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • TriHealth

    Cincinnati, Ohio, 45242, United States

  • Trident Medical Center

    North Charleston, South Carolina, 29406, United States

  • UPMC Harrisburg

    Mechanicsburg, Pennsylvania, 17050, United States

  • USF - Tampa General Hospital

    Tampa, Florida, 33620, United States

  • University of Buffalo / Kaleida Health

    Buffalo, New York, 14203, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23219, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • WellStar Kennestone Hospital

    Marietta, Georgia, 30062, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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