RecruitingNot ApplicableNCT05147792

The CONFORM Pivotal Trial

An Evaluation of the Safety and Effectiveness of the Conformal CLAAS System for Left Atrial Appendage Occlusion

Sponsor

Conformal Medical, Inc

Enrollment

1,600 participants

Start Date

May 26, 2022

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Stroke

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a device that closes off a small pouch in the heart (left atrial appendage) as an alternative to long-term blood thinners for people with atrial fibrillation who are at high stroke risk. **You may be eligible if...** - You are 18 or older with non-valvular atrial fibrillation - Your stroke risk score (CHA2DS2-VASc) is 3 or higher - You have a medical reason to avoid long-term blood thinners but can tolerate short-term anticoagulation - Both your doctor and an independent physician agree this procedure is appropriate for you - You can follow the required medication schedule and attend follow-up visits **You may NOT be eligible if...** - You are pregnant, nursing, or planning a pregnancy within one year - Your heart anatomy prevents the closure procedure - You have active infections, blood clots inside the heart, or certain other cardiac conditions - You cannot take the required medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECLAAS

CLAAS

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

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

Locations(83)

Grandview Medical Center

Birmingham, Alabama, United States

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

HonorHealth

Scottsdale, Arizona, United States

Pima Heart & Vascular

Tucson, Arizona, United States

St. Bernard's Medical Center

Jonesboro, Arkansas, United States

Loma Linda University Health

Loma Linda, California, United States

Huntington Hospital

Pasadena, California, United States

Pacific Heart Institute

Santa Monica, California, United States

Community Memorial Hospital Ventura

Ventura, California, United States

Hartford Health Care St. Vincent's Medical Center

Bridgeport, Connecticut, United States

MedStar Washington Hospital Center

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

Ascension St. Vincent's Jacksonville

Jacksonville, Florida, United States

Largo Medical Center

Largo, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Baptist Health Care - Pensacola

Pensacola, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

AdventHealth Tampa

Tampa, Florida, United States

USF - Tampa General Hospital

Tampa, Florida, United States

Piedmont Health Institute

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Northside Hospital, Inc

Atlanta, Georgia, United States

WellStar Kennestone Hospital

Marietta, Georgia, United States

Midwest Cardiovascular Institute

Naperville, Illinois, United States

Ascension St. Vincent - Carmel, IN

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Terrebone - Cardiovascular Institute of the South

Houma, Louisiana, United States

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

Lahey Hospital & Medical Centeer

Burlington, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Henry Ford St. John Hospital

Detroit, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Henry Ford Providence Southfield Hospital

Southfield, Michigan, United States

M Health Fairview St. John's Hospital

Maplewood, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Kansas City Cardiac Arrhythmia Research, LLC

Overland, Missouri, United States

CHI Health / CommonSpirit Research Institute

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Cooper University - Heart House

Haddon Heights, New Jersey, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Albany Medical Center / Capital Cardiology Associates

Albany, New York, United States

University of Buffalo / Kaleida Health

Buffalo, New York, United States

Mount Sinai Hospital

New York, New York, United States

Mission Hospital

Asheville, North Carolina, United States

TriHealth

Cincinnati, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

ProMedica Toledo Hospital

Toledo, Ohio, United States

Legacy Emanuel Hospital and Health

Portland, Oregon, United States

UPMC Harrisburg

Mechanicsburg, Pennsylvania, United States

Lankenau Heart Institute

Wynnewood, Pennsylvania, United States

Lifespan Health System

Providence, Rhode Island, United States

Prisma Health

Columbia, South Carolina, United States

Trident Medical Center

North Charleston, South Carolina, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Houston Methodist

Houston, Texas, United States

Memorial Hermann Memorial City Medical Center

Houston, Texas, United States

CHRISTUS Health

Tyler, Texas, United States

Senatra Norfolk

Norfolk, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Chippenham Hospital

Richmond, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Bellin Health

Green Bay, Wisconsin, United States

Nemocnice Na Homolce

Prague, Czechia

CHU de Bordeaux

Bordeaux, France

CHU La Timone, Marseille

Marseille, France

Institut Cardiovasculaire Paris Sud

Massy, France

CHU de Toulouse

Toulouse, France

Clinique Pasteur, Toulouse

Toulouse, France

Chapidze Heart Disease Center

Tbilisi, Georgia

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Tbilisi Heart Center

Tbilisi, Georgia

Republican Specialized Center for Surgery named after V. Vakhidov

Chilanzar, Tashkent, Uzbekistan

AKFA Medline

Olmazor, Tashkent, Uzbekistan

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NCT05147792

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