The CONFORM Pivotal Trial

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05147792
• Other study ID #: 21-101
• Status: Suspended
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: August 2030

Study information

• Verified date: May 2024
• Source: Conformal Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1600
• Est. completion date: August 2030
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Device:
• CLAAS
CLAAS
• WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

Locations

Country	Name	City	State
Georgia	Chapidze	Tbilisi
Georgia	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	Northside Hospital, Inc	Atlanta	Georgia
United States	Piedmont Health Institute	Atlanta	Georgia
United States	Medical Center of Aurora	Aurora	Colorado
United States	Medstar Union Memorial Hospital	Baltimore	Maryland
United States	Grandview Medical Center	Birmingham	Alabama
United States	University of Buffalo / Kaleida Health	Buffalo	New York
United States	Lahey Hospital & Medical Centeer	Burlington	Massachusetts
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Ascension St. John's Hospital	Detroit	Michigan
United States	Corewell Health	Grand Rapids	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Cooper University - Heart House	Haddon Heights	New Jersey
United States	Terrebone - Cardiovascular Institute of the South	Houma	Louisiana
United States	Memorial Hermann Memorial City Medical Center	Houston	Texas
United States	Ascension St. Vincent - Carmel, IN	Indianapolis	Indiana
United States	Ascension St. Vincent's Jacksonville	Jacksonville	Florida
United States	St. Bernard's Medical Center	Jonesboro	Arkansas
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee
United States	Largo Medical Center	Largo	Florida
United States	Catholic Medical Center	Manchester	New Hampshire
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Baptist Hospital of Miami	Miami	Florida
United States	West Virginia University	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	Senatra Norfolk	Norfolk	Virginia
United States	Trident Medical Center	North Charleston	South Carolina
United States	Kansas City Cardiac Arrhythmia Research, LLC	Overland	Missouri
United States	Abrazo Arizona Heart Hospital	Phoenix	Arizona
United States	Lifespan Health System	Providence	Rhode Island
United States	Chippenham Hospital	Richmond	Virginia
United States	Carilion Clinic	Roanoke	Virginia
United States	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota
United States	Pacific Heart Institute	Santa Monica	California
United States	HonorHealth	Scottsdale	Arizona
United States	Ascension Providence Hospital	Southfield	Michigan
United States	Baystate Medical Center	Springfield	Massachusetts
United States	USF - Tampa General Hospital	Tampa	Florida
United States	Pima Heart & Vascular	Tucson	Arizona
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Community Memorial Hospital Ventura	Ventura	California
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Lankenau Heart Institute	Wynnewood	Pennsylvania
Uzbekistan	Republican Specialized Center for Surgery named after V. Vakhidov	Chilanzar	Tashkent
Uzbekistan	AKFA Medline	Olmazor	Tashkent

Sponsors (1)

Lead Sponsor	Collaborator
Conformal Medical, Inc

Countries where clinical trial is conducted

United States,  Uzbekistan,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ischemic stroke and systemic embolism	The primary effectiveness endpoint is a composite of ischemic stroke and systemic embolism through 18 months.	18 months
Secondary	All Cause Mortality	A secondary safety endpoint is all-cause mortality including cardiovascular through 18 months	18 months
Secondary	Myocardial Infarction	A secondary safety endpoint is myocardial infarction evaluated through 7 days post-procedure	7 days
Secondary	Neurologic Events	A secondary safety endpoint is neurologic events including stroke (ischemic and hemorrhagic) and TIA	45 days
Secondary	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	12 months