Actively Recruiting
The CONFORM Pivotal Trial
Led by Conformal Medical, Inc · Updated on 2026-05-06
1600
Participants Needed
88
Research Sites
496 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The CONFORM Pivotal Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 years or older
- Documented non-valvular atrial fibrillation (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism with CHA2DS2-VASc score of 3 or greater
- Appropriate reason to seek a non-pharmacologic alternative to long-term oral anticoagulation
- Suitable for short-term oral anticoagulation but less favorable for long-term use as assessed by investigator
- Approved for left atrial appendage closure by investigator and a second clinician using shared decision-making
- Able to follow the medication plan and attend follow-up evaluations
- Provided informed consent approved by the appropriate ethics committee
You will not qualify if you...
- Pregnant or nursing women or planning pregnancy within one year after procedure; women of childbearing potential must have a negative pregnancy test within 7 days prior to procedure
- Anatomic conditions preventing left atrial appendage occlusion (e.g., atrial septal defect needing closure, high-risk patent foramen ovale requiring closure, presence of closure devices, history of surgical repairs)
- Atrial fibrillation that is a single occurrence, transient, or reversible (due to thyroid disorder, alcohol intoxication, trauma, recent surgery)
- Medical conditions requiring long-term oral anticoagulation other than atrial fibrillation
- History of bleeding disorders or contraindications to antiplatelet or anticoagulant therapy
- Active systemic infection
- Symptomatic carotid artery disease with significant stenosis; history of carotid stent or surgery allowed if stenosis is less than 50%
- Recent or planned major cardiac or non-cardiac surgery or intervention within specified timeframes
- Recent stroke, transient ischemic attack, or myocardial infarction within 30 days
- Vascular access issues preventing catheter delivery of implant
- Severe heart failure (NYHA Class IV)
- Prior cardiac transplant, mitral valve replacement or intervention, or any mechanical valve implant
- Renal insufficiency with estimated glomerular filtration rate below 30 mL/min/1.73 m2
- Abnormal platelet or white blood cell counts
- Allergy or contraindications to aspirin, heparin, P2Y12 inhibitors, device materials, or contrast sensitivity
- Participation in conflicting clinical trials
- Unable to undergo general anesthesia
- Other medical illnesses or substance abuse limiting compliance or life expectancy under 5 years
- Conditions preventing adequate transesophageal echocardiographic assessment
- Echocardiographic exclusions including unsuitable left atrial appendage anatomy, intracardiac thrombus, low ejection fraction, significant pericardial effusion, atrial septal defect needing closure, high-risk patent foramen ovale, moderate/severe mitral valve stenosis, complex atheroma, or cardiac tumor
AI-Screening
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Trial Site Locations
Total: 88 locations
1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
Actively Recruiting
2
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
3
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States, 85016
Active, Not Recruiting
4
Arizona Heart Arrhythmia Associates
Phoenix, Arizona, United States, 85018
Actively Recruiting
5
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
6
Pima Heart & Vascular
Tucson, Arizona, United States, 85719
Actively Recruiting
7
St. Bernard's Medical Center
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
8
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
9
Huntington Hospital
Pasadena, California, United States, 91105
Actively Recruiting
10
Pacific Heart Institute
Santa Monica, California, United States, 90405
Actively Recruiting
11
Community Memorial Hospital Ventura
Ventura, California, United States, 93003
Actively Recruiting
12
South Denver Cardiology Associates
Littleton, Colorado, United States, 80120
Actively Recruiting
13
Hartford Health Care St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Actively Recruiting
14
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
15
Ascension St. Vincent's Jacksonville
Jacksonville, Florida, United States, 32204
Active, Not Recruiting
16
Largo Medical Center
Largo, Florida, United States, 33770
Actively Recruiting
17
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Actively Recruiting
18
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
19
Baptist Health Care - Pensacola
Pensacola, Florida, United States, 32503
Actively Recruiting
20
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Actively Recruiting
21
AdventHealth Tampa
Tampa, Florida, United States, 33613
Actively Recruiting
22
USF - Tampa General Hospital
Tampa, Florida, United States, 33620
Actively Recruiting
23
Piedmont Health Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
24
Emory University
Atlanta, Georgia, United States, 30342
Actively Recruiting
25
Northside Hospital, Inc
Atlanta, Georgia, United States, 30342
Actively Recruiting
26
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30062
Actively Recruiting
27
Midwest Cardiovascular Institute
Naperville, Illinois, United States, 60540
Actively Recruiting
28
Ascension St. Vincent - Carmel, IN
Indianapolis, Indiana, United States, 46260
Active, Not Recruiting
29
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
30
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
31
Terrebone - Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
32
Medstar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
33
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
34
Lahey Hospital & Medical Centeer
Burlington, Massachusetts, United States, 01805
Actively Recruiting
35
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Actively Recruiting
36
Henry Ford St. John Hospital
Detroit, Michigan, United States, 48236
Actively Recruiting
37
Corewell Health
Grand Rapids, Michigan, United States, 49503
Active, Not Recruiting
38
Henry Ford Providence Southfield Hospital
Southfield, Michigan, United States, 48075
Actively Recruiting
39
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States, 55109
Actively Recruiting
40
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States, 56303
Actively Recruiting
41
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
Actively Recruiting
42
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
43
Kansas City Cardiac Arrhythmia Research, LLC
Overland, Missouri, United States, 66211
Actively Recruiting
44
CHI Health / CommonSpirit Research Institute
Omaha, Nebraska, United States, 68124
Actively Recruiting
45
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
46
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
Active, Not Recruiting
47
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Active, Not Recruiting
48
Cooper University - Heart House
Haddon Heights, New Jersey, United States, 08104
Actively Recruiting
49
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
50
Albany Medical Center / Capital Cardiology Associates
Albany, New York, United States, 12208
Actively Recruiting
51
University of Buffalo / Kaleida Health
Buffalo, New York, United States, 14203
Actively Recruiting
52
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
53
Mission Hospital
Asheville, North Carolina, United States, 28801
Actively Recruiting
54
TriHealth
Cincinnati, Ohio, United States, 45242
Actively Recruiting
55
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
Active, Not Recruiting
56
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
57
Legacy Emanuel Hospital and Health
Portland, Oregon, United States, 97228
Actively Recruiting
58
UPMC Harrisburg
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
59
Lankenau Heart Institute
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
60
Lifespan Health System
Providence, Rhode Island, United States, 02903
Active, Not Recruiting
61
Prisma Health
Columbia, South Carolina, United States, 29203
Actively Recruiting
62
HCA Grand Strand
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
63
Trident Medical Center
North Charleston, South Carolina, United States, 29406
Actively Recruiting
64
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Active, Not Recruiting
65
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
Actively Recruiting
66
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
67
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
68
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States, 77094
Actively Recruiting
69
CHRISTUS Health
Tyler, Texas, United States, 75701
Actively Recruiting
70
Sentara Norfolk
Norfolk, Virginia, United States, 23507
Active, Not Recruiting
71
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
72
Chippenham Hospital
Richmond, Virginia, United States, 23225
Actively Recruiting
73
Carilion Clinic
Roanoke, Virginia, United States, 24014
Actively Recruiting
74
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
75
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
76
Bellin Health
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
77
Nemocnice Na Homolce
Prague, Czechia, 150 00
Active, Not Recruiting
78
CHU de Bordeaux
Bordeaux, France, 33604
Actively Recruiting
79
CHU La Timone, Marseille
Marseille, France, 13005
Actively Recruiting
80
Institut Cardiovasculaire Paris Sud
Massy, France, 91300
Actively Recruiting
81
CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
82
Clinique Pasteur, Toulouse
Toulouse, France, 31076
Actively Recruiting
83
Chapidze Heart Disease Center
Tbilisi, Georgia
Active, Not Recruiting
84
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
Active, Not Recruiting
85
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Active, Not Recruiting
86
Tbilisi Heart Center
Tbilisi, Georgia
Active, Not Recruiting
87
Republican Specialized Center for Surgery named after V. Vakhidov
Chilanzar, Tashkent, Uzbekistan, 100115
Active, Not Recruiting
88
AKFA Medline
Olmazor, Tashkent, Uzbekistan, 100211
Active, Not Recruiting
Research Team
S
Sarah Gallagher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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