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The CONFORM Pivotal Trial | Clinical Trials | Clareo Health

RECRUITINGNA

The CONFORM Pivotal Trial

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

NCT05147792•Conformal Medical, Inc

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
•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
+11 more criteria

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
•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 prior to implant
•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 more criteria

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

Key Dates

Start Date

May 26, 2022

Primary Completion Date

June 1, 2028

Completion Date

December 1, 2031

Last Updated

March 18, 2026

Enrollment

1,600

ESTIMATED participants

Conditions

Atrial FibrillationStroke

Interventions

CLAAS

DEVICE

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

DEVICE

Contacts

Sarah Gallagher

CONTACT

952-270-8356 sgallagher@conformalmedical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The CONFORM Pivotal Trial

Inclusion Criteria

Exclusion Criteria

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