The CONFORM Pivotal Trial
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient 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 prior to implant 3. Left ventricular ejection fraction (LVEF) <30% 4. Moderate or large circumferential 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CLAAS |
Transcatheter left atrial occluder |
|
|
Active Comparator WATCHMAN / Amulet |
Transcatheter left atrial occluder |
|
Recruiting Locations
Grandview Medical Center
Birmingham, Alabama 35243
Birmingham, Alabama 35243
St. Bernard's Medical Center
Jonesboro, Arkansas 72401
Jonesboro, Arkansas 72401
Pacific Heart Institute
Santa Monica, California 90405
Santa Monica, California 90405
Community Memorial Hospital Ventura
Ventura, California 93003
Ventura, California 93003
WellStar Kennestone Hospital
Marietta, Georgia 30062
Marietta, Georgia 30062
Midwest Cardiovascular Institute
Naperville, Illinois 60540
Naperville, Illinois 60540
Terrebone - Cardiovascular Institute of the South
Houma, Louisiana 70360
Houma, Louisiana 70360
Medstar Union Memorial Hospital
Baltimore, Maryland 21218
Baltimore, Maryland 21218
Baystate Medical Center
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
CHI Health / CommonSpirit Research Institute
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Albany Medical Center / Capital Cardiology Associates
Albany, New York 12208
Albany, New York 12208
University of Buffalo / Kaleida Health
Buffalo, New York 14203
Buffalo, New York 14203
Erlanger Health System
Chattanooga, Tennessee 37403
Chattanooga, Tennessee 37403
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Memorial Hermann Memorial City Medical Center
Houston, Texas 77094
Houston, Texas 77094
CHRISTUS Health
Tyler, Texas 75701
Tyler, Texas 75701
Chippenham Hospital
Richmond, Virginia 23225
Richmond, Virginia 23225
West Virginia University
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
More Details
- NCT ID
- NCT05147792
- Status
- Recruiting
- Sponsor
- Conformal Medical, Inc