The CONFORM Pivotal Trial

August 17, 2026 updated by: Conformal Medical, Inc

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 150 00
        • Nemocnice Na Homolce
  • France
      • Bordeaux, France, 33604
        • CHU de Bordeaux
      • Marseille, France, 13005
        • CHU La Timone, Marseille
      • Massy, France, 91300
        • Institut Cardiovasculaire Paris Sud
      • Toulouse, France, 31059
        • CHU de Toulouse
      • Toulouse, France, 31076
        • Clinique Pasteur, Toulouse
  • Georgia
      • Tbilisi, Georgia
        • Tbilisi Heart and Vascular Clinic
      • Tbilisi, Georgia
        • Israeli-Georgian Medical Research Clinic Helsicore
      • Tbilisi, Georgia
        • Tbilisi Heart Center
      • Tbilisi, Georgia
        • Chapidze Heart Disease Center
  • Germany
      • Essen, Germany, 45138
        • Elisabeth Krankenhaus
      • Frankfurt, Germany, 60389
        • Cardiovasculäres Centrum Frankfurt
      • Hamburg, Germany, 22763
        • Asklepios Klinik-Altona
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Grandview Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center Phoenix
      • Phoenix, Arizona, United States, 85016
        • Abrazo Arizona Heart Hospital
      • Phoenix, Arizona, United States, 85018
        • Arizona Heart Arrhythmia Associates
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth
      • Tucson, Arizona, United States, 85719
        • Pima Heart & Vascular
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • St. Bernard's Medical Center
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University health
      • Pasadena, California, United States, 91105
        • Huntington Hospital
      • Santa Monica, California, United States, 90405
        • Pacific Heart Institute
      • Ventura, California, United States, 93003
        • Community Memorial Hospital Ventura
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Hartford Health Care St. Vincent's Medical Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Ascension St. Vincent's Jacksonville
      • Largo, Florida, United States, 33770
        • Largo Medical Center
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Pensacola, Florida, United States, 32503
        • Baptist Health Care - Pensacola
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Health Care System
      • Tampa, Florida, United States, 33613
        • AdventHealth Tampa
      • Tampa, Florida, United States, 33620
        • USF - Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital, Inc
      • Atlanta, Georgia, United States, 30342
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Piedmont Health Institute
      • Marietta, Georgia, United States, 30062
        • Wellstar Kennestone Hospital
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Midwest Cardiovascular Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension St. Vincent - Carmel, IN
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Terrebone - Cardiovascular Institute of the South
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21218
        • Medstar Union Memorial Hospital
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Centeer
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Henry Ford St. John Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health
      • Southfield, Michigan, United States, 48075
        • Henry Ford Providence Southfield Hospital
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • M Health Fairview St. John's Hospital
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Heart and Vascular Center
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Overland, Missouri, United States, 66211
        • Kansas City Cardiac Arrhythmia Research, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68124
        • CHI Health / CommonSpirit Research Institute
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Haddon Heights, New Jersey, United States, 08104
        • Cooper University - Heart House
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center / Capital Cardiology Associates
      • Buffalo, New York, United States, 14203
        • University of Buffalo / Kaleida Health
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • TriHealth
      • Columbus, Ohio, United States, 43214
        • Ohio Health Research Institute
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, United States, 17050
        • UPMC Harrisburg
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Heart Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Lifespan Health System
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Prisma Health
      • Myrtle Beach, South Carolina, United States, 29572
        • HCA Grand Strand
      • North Charleston, South Carolina, United States, 29406
        • Trident Medical Center
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System
      • Knoxville, Tennessee, United States, 37934
        • Tennova Healthcare - Turkey Creek Medical Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Houston, Texas, United States, 77094
        • Memorial Hermann Memorial City Medical Center
      • Plano, Texas, United States, 75093
        • Baylor Scott & White Research Institute
      • Tyler, Texas, United States, 75701
        • CHRISTUS Health
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23225
        • Chippenham Hospital
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Bellin Health
  • Uzbekistan
    • Tashkent
      • Chilanzar, Tashkent, Uzbekistan, 100115
        • Republican Specialized Center for Surgery named after V. Vakhidov
      • Olmazor, Tashkent, Uzbekistan, 100211
        • AKFA Medline

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLAAS
Transcatheter left atrial occluder
Device: CLAAS
CLAAS
Active Comparator: WATCHMAN / Amulet
Transcatheter left atrial occluder
Device: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related complications, all-cause death, major bleeding
Time Frame: 12 months
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
Time Frame: 18 months
The primary effectiveness endpoint is a composite of ischemic stroke and systemic embolism through 18 months.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related complications, all-cause death, major bleeding
Time Frame: 5 years
All elements of the Primary Safety Endpoint will be reported descriptively for all subjects through 5 years: 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
5 years
Device Success
Time Frame: Procedure
A secondary performance and efficacy endpoint is Device Success, defined as LAAO device deployed and implanted in correct position
Procedure
Technical success
Time Frame: 45 days
A secondary performance and efficacy endpoint is Technical Success, defined as Device Success, complete closure or peri-device residual leak ≤5 mm in width on TEE, as evaluated by independent imaging core lab without device-related complications [evaluated post-procedure].
45 days
Procedure success
Time Frame: 7 Days
A secondary performance and efficacy endpoint is Procedure Success, defined as Technical Success without in-hospital major procedure-related complications (excluding minor device embolization) evaluated at hospitalization or at 7 days whichever is first.
7 Days
Embolic Events
Time Frame: 12 Months, 18 Months
A secondary performance and efficacy endpoint is Embolic Events, defined as ischemic stroke as defined by NeuroARC (29) and systemic thromboembolism characterized as any thromboemboli in the arterial system.
12 Months, 18 Months
Closure Success
Time Frame: 12 months
A secondary performance and efficacy endpoint is Closure Success at 12 months based upon each of the following criteria: a) demonstration of peri-device leak </=5 mm, and b) demonstration of peri-device leak </=3 mm
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conformal Medical, Inc

Investigators

  • Principal Investigator: William Gray, M.D., Lankenau Heart Institute
  • Principal Investigator: Shephal Doshi, M.D., Pacific Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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