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

Status: Recruiting
Location: See all (70) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alabama
Grandview Medical Center
RECRUITING
Birmingham
Arkansas
St. Bernard's Medical Center
RECRUITING
Jonesboro
Arizona
Abrazo Arizona Heart Hospital
ACTIVE_NOT_RECRUITING
Phoenix
HonorHealth
RECRUITING
Scottsdale
Pima Heart & Vascular
ACTIVE_NOT_RECRUITING
Tucson
California
Huntington Hospital
RECRUITING
Pasadena
Pacific Heart Institute
RECRUITING
Santa Monica
Community Memorial Hospital Ventura
RECRUITING
Ventura
Washington, D.c.
MedStar Washington Hospital Center
ACTIVE_NOT_RECRUITING
Washington D.c.
Florida
Ascension St. Vincent's Jacksonville
ACTIVE_NOT_RECRUITING
Jacksonville
Largo Medical Center
RECRUITING
Largo
Baptist Hospital of Miami
RECRUITING
Miami
AdventHealth Orlando
RECRUITING
Orlando
Sarasota Memorial Health Care System
RECRUITING
Sarasota
AdventHealth Tampa
RECRUITING
Tampa
USF - Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Northside Hospital, Inc
RECRUITING
Atlanta
Piedmont Health Institute
RECRUITING
Atlanta
WellStar Kennestone Hospital
RECRUITING
Marietta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Midwest Cardiovascular Institute
RECRUITING
Naperville
Indiana
Ascension St. Vincent - Carmel, IN
ACTIVE_NOT_RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Louisiana
Terrebone - Cardiovascular Institute of the South
RECRUITING
Houma
Massachusetts
Lahey Hospital & Medical Centeer
RECRUITING
Burlington
Baystate Medical Center
RECRUITING
Springfield
Maryland
Medstar Union Memorial Hospital
RECRUITING
Baltimore
Michigan
Henry Ford St. John Hospital
RECRUITING
Detroit
Corewell Health
ACTIVE_NOT_RECRUITING
Grand Rapids
Henry Ford Providence Southfield Hospital
ACTIVE_NOT_RECRUITING
Southfield
Minnesota
M Health Fairview St. John's Hospital
RECRUITING
Maplewood
CentraCare Heart and Vascular Center
RECRUITING
Saint Cloud
Missouri
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
Kansas City Cardiac Arrhythmia Research, LLC
RECRUITING
Overland Park
Mississippi
North Mississippi Medical Center
RECRUITING
Tupelo
North Carolina
Mission Hospital
RECRUITING
Asheville
Nebraska
CHI Health / CommonSpirit Research Institute
RECRUITING
Omaha
New Hampshire
Catholic Medical Center
ACTIVE_NOT_RECRUITING
Manchester
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Cooper University - Heart House
RECRUITING
Haddon Heights
New York
Albany Medical Center / Capital Cardiology Associates
RECRUITING
Albany
University of Buffalo / Kaleida Health
RECRUITING
Buffalo
Mount Sinai Hospital
RECRUITING
New York
Ohio
TriHealth
RECRUITING
Cincinnati
Ohio Health Research Institute
ACTIVE_NOT_RECRUITING
Columbus
ProMedica Toledo Hospital
RECRUITING
Toledo
Oregon
Legacy Emanuel Hospital and Health
RECRUITING
Portland
Pennsylvania
UPMC Harrisburg
RECRUITING
Mechanicsburg
Lankenau Heart Institute
RECRUITING
Wynnewood
Rhode Island
Lifespan Health System
ACTIVE_NOT_RECRUITING
Providence
South Carolina
Trident Medical Center
RECRUITING
North Charleston
Tennessee
Erlanger Health System
RECRUITING
Chattanooga
Tennova Healthcare - Turkey Creek Medical Center
RECRUITING
Knoxville
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Houston Methodist
RECRUITING
Houston
Memorial Hermann Memorial City Medical Center
RECRUITING
Houston
CHRISTUS Health
RECRUITING
Tyler
Virginia
Senatra Norfolk
RECRUITING
Norfolk
Chippenham Hospital
RECRUITING
Richmond
Virginia Commonwealth University
RECRUITING
Richmond
Carilion Clinic
RECRUITING
Roanoke
West Virginia
West Virginia University
RECRUITING
Morgantown
Other Locations
France
Hôpital Privé Jacques Cartier
RECRUITING
Massy
Georgia
Chapidze Heart Disease Center
RECRUITING
Tbilisi
Israeli-Georgian Medical Research Clinic Helsicore
RECRUITING
Tbilisi
Tbilisi Heart and Vascular Clinic
RECRUITING
Tbilisi
Tbilisi Heart Center
RECRUITING
Tbilisi
Uzbekistan
Republican Specialized Center for Surgery named after V. Vakhidov
ACTIVE_NOT_RECRUITING
Chilanzar
AKFA Medline
ACTIVE_NOT_RECRUITING
Olmazor
Contact Information
Primary
Aly Dechert, MS
adechert@conformalmedical.com
603-718-8742
Time Frame
Start Date: 2022-05-26
Estimated Completion Date: 2031-12
Participants
Target number of participants: 1600
Treatments
Experimental: CLAAS
Transcatheter left atrial occluder
Active_comparator: WATCHMAN / Amulet
Transcatheter left atrial occluder
Related Therapeutic Areas
Sponsors
Leads: Conformal Medical, Inc

This content was sourced from clinicaltrials.gov