The CONFORM Pivotal Trial
- Conditions
- StrokeAtrial Fibrillation
- Interventions
- Device: CLAASDevice: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
- Registration Number
- NCT05147792
- Lead Sponsor
- Conformal Medical, Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1600
- Male or non-pregnant female aged ≥18 years
- Documented non-valvular AF (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
- Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
- Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
- 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
- Able to comply with the protocol-specified medication regimen and follow-up evaluations
- 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).
- 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.
- 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)
- 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)
- 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)
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
- Documented active systemic infection
- 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
- Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
- Recent (within 30 days of index procedure) stroke or transient ischemic attack
- Recent (within 30 days of index procedure) myocardial infarction
- Vascular access precluding delivery of implant with catheter-based system
- Severe heart failure (New York Heart Association Class IV)
- Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
- Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
- Platelet count <75,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3
- 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
- Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- Unable to undergo general anesthesia
- 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
- A condition which precludes adequate transesophageal echocardiographic assessment
Echo exclusion criteria:
- 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)
- Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE prior to implant
- Left ventricular ejection fraction (LVEF) <30%
- 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
- Atrial septal defect that warrants closure
- 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)
- Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
- Evidence of cardiac tumor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CLAAS CLAAS Transcatheter left atrial occluder WATCHMAN / Amulet WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder Transcatheter left atrial occluder
- Primary Outcome Measures
Name Time Method Ischemic stroke and systemic embolism 18 months The primary effectiveness endpoint is a composite of ischemic stroke and systemic embolism through 18 months.
Procedure-related complications, all-cause death, major bleeding 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
- Secondary Outcome Measures
Name Time Method All Cause Mortality 18 months A secondary safety endpoint is all-cause mortality including cardiovascular through 18 months
Neurologic Events 45 days A secondary safety endpoint is neurologic events including stroke (ischemic and hemorrhagic) and TIA
Myocardial Infarction 7 days A secondary safety endpoint is myocardial infarction evaluated through 7 days post-procedure
Closure Success 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 flow \</=5 mm, and b) demonstration of peri-device flow \</=3 mm
Trial Locations
- Locations (60)
Grandview Medical Center
🇺🇸Birmingham, Alabama, 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
Pacific Heart Institute
🇺🇸Santa Monica, California, United States
Community Memorial Hospital Ventura
🇺🇸Ventura, California, United States
MedStar Washington Hospital Center
🇺🇸Washington, 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
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 Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, 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
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
CentraCare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Henry Ford St. John Hospital
🇺🇸Detroit, Michigan, 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
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Henry Ford Providence Southfield Hospital
🇺🇸Southfield, Michigan, United States
M Health Fairview St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Cooper University - Heart House
🇺🇸Haddon Heights, New Jersey, 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
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Lankenau Heart Institute
🇺🇸Wynnewood, Pennsylvania, United States
Lifespan Health System
🇺🇸Providence, Rhode Island, 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
Chippenham Hospital
🇺🇸Richmond, Virginia, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
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