The CONFORM Pivotal Trial

NCT05147792 | Recruiting DMC FDA Device

• 1 other identifier: 21-101
• Study Type: interventional
• Target: 1,600
• Locations: 5 countries
• Sites: 88

Brief Summary

The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (2)

• Procedure-related complications, all-cause death, major bleeding

  The primary safety endpoint is a composite of 1) major procedure-related complications including a) cardiac perforation, b) pericardial effusion requiring drainage, c) ischemic stroke, d) device embolization, and e) major vascular complications, or 2) major bleeding, or 3) all-cause death

  12 months

• Ischemic stroke and systemic embolism

  The primary effectiveness endpoint is a composite of ischemic stroke and systemic embolism through 18 months.

  18 months

Secondary Outcomes (6)

• Procedure-related complications, all-cause death, major bleeding

  5 years

• Device Success

  Procedure

• Technical success

  45 days

• Procedure success

  7 Days

• Embolic Events

  12 Months, 18 Months

Study Arms (2)

CLAAS

EXPERIMENTAL

Transcatheter left atrial occluder

Device: CLAAS

WATCHMAN / Amulet

ACTIVE COMPARATOR

Transcatheter left atrial occluder

Device: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

Interventions

CLAAS DEVICE

CLAAS

CLAAS

WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder DEVICE

WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

WATCHMAN / Amulet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, or permanent)
• High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
• Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
• Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
• 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
• Able to comply with the protocol-specified medication regimen and follow-up evaluations
• 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).

You may not qualify if:

• 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.
• 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)
• 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)
• 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)
• History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
• Documented active systemic infection
• 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
• Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
• Recent (within 30 days of index procedure) stroke or transient ischemic attack
• Recent (within 30 days of index procedure) myocardial infarction
• Vascular access precluding delivery of implant with catheter-based system
• Severe heart failure (New York Heart Association Class IV)
• Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
• Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3

Sponsors & Collaborators

• Conformal Medical, Inc: lead

Study Sites (88)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

RECRUITING

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States

ACTIVE NOT RECRUITING

Arizona Heart Arrhythmia Associates

Phoenix, Arizona, 85018, United States

RECRUITING

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

Pima Heart & Vascular

Tucson, Arizona, 85719, United States

RECRUITING

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

RECRUITING

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

Huntington Hospital

Pasadena, California, 91105, United States

RECRUITING

Pacific Heart Institute

Santa Monica, California, 90405, United States

RECRUITING

Community Memorial Hospital Ventura

Ventura, California, 93003, United States

RECRUITING

South Denver Cardiology Associates

Littleton, Colorado, 80120, United States

RECRUITING

Hartford Health Care St. Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

RECRUITING

MedStar Washington Hospital Center

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

RECRUITING

Ascension St. Vincent's Jacksonville

Jacksonville, Florida, 32204, United States

ACTIVE NOT RECRUITING

Largo Medical Center

Largo, Florida, 33770, United States

RECRUITING

Baptist Hospital of Miami

Miami, Florida, 33176, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Baptist Health Care - Pensacola

Pensacola, Florida, 32503, United States

RECRUITING

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

RECRUITING

AdventHealth Tampa

Tampa, Florida, 33613, United States

RECRUITING

USF - Tampa General Hospital

Tampa, Florida, 33620, United States

RECRUITING

Piedmont Health Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Emory University

Atlanta, Georgia, 30342, United States

RECRUITING

Northside Hospital, Inc

Atlanta, Georgia, 30342, United States

RECRUITING

WellStar Kennestone Hospital

Marietta, Georgia, 30062, United States

RECRUITING

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

RECRUITING

Ascension St. Vincent - Carmel, IN

Indianapolis, Indiana, 46260, United States

ACTIVE NOT RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Terrebone - Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Lahey Hospital & Medical Centeer

Burlington, Massachusetts, 01805, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

Henry Ford St. John Hospital

Detroit, Michigan, 48236, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

ACTIVE NOT RECRUITING

Henry Ford Providence Southfield Hospital

Southfield, Michigan, 48075, United States

RECRUITING

M Health Fairview St. John's Hospital

Maplewood, Minnesota, 55109, United States

RECRUITING

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

RECRUITING

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

RECRUITING

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Kansas City Cardiac Arrhythmia Research, LLC

Overland, Missouri, 66211, United States

RECRUITING

CHI Health / CommonSpirit Research Institute

Omaha, Nebraska, 68124, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

ACTIVE NOT RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

ACTIVE NOT RECRUITING

Cooper University - Heart House

Haddon Heights, New Jersey, 08104, United States

RECRUITING

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

RECRUITING

Albany Medical Center / Capital Cardiology Associates

Albany, New York, 12208, United States

RECRUITING

University of Buffalo / Kaleida Health

Buffalo, New York, 14203, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, United States

RECRUITING

TriHealth

Cincinnati, Ohio, 45242, United States

RECRUITING

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

ACTIVE NOT RECRUITING

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

Legacy Emanuel Hospital and Health

Portland, Oregon, 97228, United States

RECRUITING

UPMC Harrisburg

Mechanicsburg, Pennsylvania, 17050, United States

RECRUITING

Lankenau Heart Institute

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Lifespan Health System

Providence, Rhode Island, 02903, United States

ACTIVE NOT RECRUITING

Prisma Health

Columbia, South Carolina, 29203, United States

RECRUITING

HCA Grand Strand

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Trident Medical Center

North Charleston, South Carolina, 29406, United States

RECRUITING

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

ACTIVE NOT RECRUITING

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77094, United States

RECRUITING

CHRISTUS Health

Tyler, Texas, 75701, United States

RECRUITING

Sentara Norfolk

Norfolk, Virginia, 23507, United States

ACTIVE NOT RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

RECRUITING

Chippenham Hospital

Richmond, Virginia, 23225, United States

RECRUITING

Carilion Clinic

Roanoke, Virginia, 24014, United States

RECRUITING

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

Bellin Health

Green Bay, Wisconsin, 54301, United States

RECRUITING

Nemocnice Na Homolce

Prague, 150 00, Czechia

ACTIVE NOT RECRUITING

CHU de Bordeaux

Bordeaux, 33604, France

RECRUITING

CHU La Timone, Marseille

Marseille, 13005, France

RECRUITING

Institut Cardiovasculaire Paris Sud

Massy, 91300, France

RECRUITING

CHU de Toulouse

Toulouse, 31059, France

RECRUITING

Clinique Pasteur, Toulouse

Toulouse, 31076, France

RECRUITING

Chapidze Heart Disease Center

Tbilisi, Georgia

ACTIVE NOT RECRUITING

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

ACTIVE NOT RECRUITING

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

ACTIVE NOT RECRUITING

Tbilisi Heart Center

Tbilisi, Georgia

ACTIVE NOT RECRUITING

Republican Specialized Center for Surgery named after V. Vakhidov

Chilanzar, Tashkent, 100115, Uzbekistan

ACTIVE NOT RECRUITING

AKFA Medline

Olmazor, Tashkent, 100211, Uzbekistan

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• William Gray, M.D.

  Lankenau Heart Institute

  PRINCIPAL INVESTIGATOR

• Shephal Doshi, M.D.

  Pacific Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Gallagher

CONTACT

952-270-8356; sgallagher@conformalmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: May 26, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); GE (4); US (76); FR (5); UZ (2)