The CONFORM Pivotal Trial

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Device: CLAAS; Device: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Tbilisi Heart and Vascular Clinic
  • Tbilisi, Georgia
    • Israeli-Georgian Medical Research Clinic Helsicore
  • Tbilisi, Georgia
    • Chapidze
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Abrazo Arizona Heart Hospital
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
    • Tucson, Arizona, United States, 85719
      • Pima Heart & Vascular
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernard's Medical Center
  • California
    • Santa Monica, California, United States, 90405
      • Pacific Heart Institute
    • Ventura, California, United States, 93003
      • Community Memorial Hospital Ventura
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Medical Center of Aurora
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Ascension St. Vincent's Jacksonville
    • Largo, Florida, United States, 33770
      • Largo Medical Center
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Tampa, Florida, United States, 33620
      • USF - Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital, Inc
    • Atlanta, Georgia, United States, 30342
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Piedmont Health Institute
    • Marietta, Georgia, United States, 30062
      • Wellstar Kennestone Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Ascension St. Vincent - Carmel, IN
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Terrebone - Cardiovascular Institute of the South
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital & Medical Centeer
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Ascension St. John's Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health
    • Southfield, Michigan, United States, 48075
      • Ascension Providence Hospital
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • Centracare Heart and Vascular Center
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Overland, Missouri, United States, 66211
      • Kansas City Cardiac Arrhythmia Research, LLC
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Haddon Heights, New Jersey, United States, 08104
      • Cooper University - Heart House
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo / Kaleida Health
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Heart Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Lifespan Health System
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Trident Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System
    • Knoxville, Tennessee, United States, 37934
      • Tennova Healthcare - Turkey Creek Medical Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77094
      • Memorial Hermann Memorial City Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Senatra Norfolk
    • Richmond, Virginia, United States, 23225
      • Chippenham Hospital
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
• Uzbekistan
  • Tashkent
    • Chilanzar, Tashkent, Uzbekistan, 100115
      • Republican Specialized Center for Surgery named after V. Vakhidov
    • Olmazor, Tashkent, Uzbekistan, 100211
      • AKFA Medline

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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 CHADS2 score of >2 or 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 patient (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:

1. 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., prior atrial septal defect [ASD] or high-risk patent foramen ovale [PFO], surgical repair or implanted closure device, or obliterated or ligated left atrial appendage)
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 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 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 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 device per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both devices 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLAAS; Transcatheter left atrial occluder	Device: CLAAS; CLAAS
Active Comparator: WATCHMAN / Amulet; Transcatheter left atrial occluder	Device: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder; WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related complications, all-cause death, major bleeding	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	12 months
Ischemic stroke and systemic embolism	The primary effectiveness endpoint is a composite of ischemic stroke and systemic embolism through 18 months.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cause Mortality	A secondary safety endpoint is all-cause mortality including cardiovascular through 18 months	18 months
Myocardial Infarction	A secondary safety endpoint is myocardial infarction evaluated through 7 days post-procedure	7 days
Neurologic Events	A secondary safety endpoint is neurologic events including stroke (ischemic and hemorrhagic) and TIA	45 days
Closure Success	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	12 months

Collaborators and Investigators

• Sponsor: Conformal Medical, Inc
• Investigators: Principal Investigator: William Gray, M.D., Lankenau Heart Institute; Principal Investigator: Shephal Doshi, M.D., Pacific Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 21-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes