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 Sex
- 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 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 4049979, Alabama 4829764 35243
Birmingham 4049979, Alabama 4829764 35243
HonorHealth
Scottsdale 5313457, Arizona 5551752 85258
Scottsdale 5313457, Arizona 5551752 85258
St. Bernard's Medical Center
Jonesboro 4116834, Arkansas 4099753 72401
Jonesboro 4116834, Arkansas 4099753 72401
Huntington Hospital
Pasadena 5381396, California 5332921 91105
Pasadena 5381396, California 5332921 91105
Pacific Heart Institute
Santa Monica 5393212, California 5332921 90405
Santa Monica 5393212, California 5332921 90405
Community Memorial Hospital Ventura
Ventura 5405878, California 5332921 93003
Ventura 5405878, California 5332921 93003
Largo Medical Center
Largo 4161580, Florida 4155751 33770
Largo 4161580, Florida 4155751 33770
Baptist Hospital of Miami
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
Orlando 4167147, Florida 4155751 32803
Sarasota Memorial Health Care System
Sarasota 4172131, Florida 4155751 34239
Sarasota 4172131, Florida 4155751 34239
AdventHealth Tampa
Tampa 4174757, Florida 4155751 33613
Tampa 4174757, Florida 4155751 33613
Piedmont Health Institute
Atlanta 4180439, Georgia 4197000 30309
Atlanta 4180439, Georgia 4197000 30309
Emory University
Atlanta 4180439, Georgia 4197000 30342
Atlanta 4180439, Georgia 4197000 30342
Northside Hospital, Inc
Atlanta 4180439, Georgia 4197000 30342
Atlanta 4180439, Georgia 4197000 30342
WellStar Kennestone Hospital
Marietta 4207783, Georgia 4197000 30062
Marietta 4207783, Georgia 4197000 30062
Midwest Cardiovascular Institute
Naperville 4903279, Illinois 4896861 60540
Naperville 4903279, Illinois 4896861 60540
University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Terrebone - Cardiovascular Institute of the South
Houma 4328010, Louisiana 4331987 70360
Houma 4328010, Louisiana 4331987 70360
Medstar Union Memorial Hospital
Baltimore 4347778, Maryland 4361885 21218
Baltimore 4347778, Maryland 4361885 21218
Lahey Hospital & Medical Centeer
Burlington 4931737, Massachusetts 6254926 01805
Burlington 4931737, Massachusetts 6254926 01805
Baystate Medical Center
Springfield 4951788, Massachusetts 6254926 01199
Springfield 4951788, Massachusetts 6254926 01199
Henry Ford St. John Hospital
Detroit 4990729, Michigan 5001836 48236
Detroit 4990729, Michigan 5001836 48236
M Health Fairview St. John's Hospital
Maplewood 5036588, Minnesota 5037779 55109
Maplewood 5036588, Minnesota 5037779 55109
CentraCare Heart and Vascular Center
Saint Cloud 5044407, Minnesota 5037779 56303
Saint Cloud 5044407, Minnesota 5037779 56303
North Mississippi Medical Center
Tupelo 4448903, Mississippi 4436296 38801
Tupelo 4448903, Mississippi 4436296 38801
Saint Luke's Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64111
Kansas City 4393217, Missouri 4398678 64111
Kansas City Cardiac Arrhythmia Research, LLC
Overland Park, Missouri 4398678 66211
Overland Park, Missouri 4398678 66211
CHI Health / CommonSpirit Research Institute
Omaha 5074472, Nebraska 5073708 68124
Omaha 5074472, Nebraska 5073708 68124
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
Cooper University - Heart House
Haddon Heights 4502093, New Jersey 5101760 08104
Haddon Heights 4502093, New Jersey 5101760 08104
Albany Medical Center / Capital Cardiology Associates
Albany 5106834, New York 5128638 12208
Albany 5106834, New York 5128638 12208
University of Buffalo / Kaleida Health
Buffalo 5110629, New York 5128638 14203
Buffalo 5110629, New York 5128638 14203
Mount Sinai Hospital
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
Mission Hospital
Asheville 4453066, North Carolina 4482348 28801
Asheville 4453066, North Carolina 4482348 28801
TriHealth
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45242
ProMedica Toledo Hospital
Toledo 5174035, Ohio 5165418 43606
Toledo 5174035, Ohio 5165418 43606
Legacy Emanuel Hospital and Health
Portland 5746545, Oregon 5744337 97228
Portland 5746545, Oregon 5744337 97228
UPMC Harrisburg
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Lankenau Heart Institute
Wynnewood 5220230, Pennsylvania 6254927 19096
Wynnewood 5220230, Pennsylvania 6254927 19096
Trident Medical Center
North Charleston 4589387, South Carolina 4597040 29406
North Charleston 4589387, South Carolina 4597040 29406
Erlanger Health System
Chattanooga 4612862, Tennessee 4662168 37403
Chattanooga 4612862, Tennessee 4662168 37403
Tennova Healthcare - Turkey Creek Medical Center
Knoxville 4634946, Tennessee 4662168 37934
Knoxville 4634946, Tennessee 4662168 37934
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
Houston Methodist
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Memorial Hermann Memorial City Medical Center
Houston 4699066, Texas 4736286 77094
Houston 4699066, Texas 4736286 77094
CHRISTUS Health
Tyler 4738214, Texas 4736286 75701
Tyler 4738214, Texas 4736286 75701
Senatra Norfolk
Norfolk 4776222, Virginia 6254928 23507
Norfolk 4776222, Virginia 6254928 23507
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23219
Richmond 4781708, Virginia 6254928 23219
Chippenham Hospital
Richmond 4781708, Virginia 6254928 23225
Richmond 4781708, Virginia 6254928 23225
Carilion Clinic
Roanoke 4782167, Virginia 6254928 24014
Roanoke 4782167, Virginia 6254928 24014
West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
Morgantown 4815352, West Virginia 4826850 26506
More Details
- NCT ID
- NCT05147792
- Status
- Recruiting
- Sponsor
- Conformal Medical, Inc