The CONFORM Pivotal Trial

Not Applicable

Suspended

• Conditions: Atrial Fibrillation; Stroke

• Registration Number: NCT05147792
• Lead Sponsor: Conformal Medical, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or non-pregnant female aged =18 years<br><br> 2. Documented non-valvular AF (paroxysmal, persistent, or permanent)<br><br> 3. High risk of stroke or systemic embolism, defined as CHADS2 score of >2 or<br> CHA2DS2-VASc score of = 3<br><br> 4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term<br> oral anticoagulation<br><br> 5. Deemed by the site investigator to be suitable for short term oral anticoagulation<br> therapy but deemed less favorable for long-term oral anticoagulation therapy.<br><br> 6. Deemed appropriate for LAA closure by the site investigator and a clinician not a<br> part of the procedural team using a shared decision-making process in accordance<br> with standard of care<br><br> 7. Able to comply with the protocol-specified medication regimen and follow-up<br> evaluations<br><br> 8. The patient (or legally authorized representative, where allowed) has been informed<br> of the nature of the study, agrees to its provisions, and has provided written<br> informed consent approved by the appropriate institutional review board<br> (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).<br><br>Exclusion Criteria:<br><br> 1. Pregnant or nursing patients and those who plan pregnancy in the period up to one<br> year following the index procedure. Female patients of childbearing potential must<br> have a negative pregnancy test (per site standard test) within 7 days prior to index<br> procedure.<br><br> 2. Anatomic conditions that would prevent performance of an LAA occlusion procedure<br> (e.g., prior atrial septal defect [ASD] or high-risk patent foramen ovale [PFO],<br> surgical repair or implanted closure device, or obliterated or ligated left atrial<br> appendage)<br><br> 3. Atrial fibrillation that is defined by a single occurrence or that is transient or<br> reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma,<br> recent major surgical procedures)<br><br> 4. A medical condition (other than atrial fibrillation) that mandates long-term oral<br> anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary<br> embolism, or mechanical heart valve)<br><br> 5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet<br> and/or anticoagulant therapy is contraindicated<br><br> 6. Documented active systemic infection<br><br> 7. Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of<br> ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral<br> hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent<br> or endarterectomy the subject is eligible if there is <50% stenosis noted at the<br> site of prior treatment<br><br> 8. Recent (within 30 days of index procedure) or planned (within 60 days<br> post-procedure) cardiac or non-cardiac interventional or surgical procedure<br><br> 9. Recent (within 30 days of index procedure) stroke or transient ischemic attack<br><br> 10. Recent (within 30 days of index procedure) myocardial infarction<br><br> 11. Vascular access precluding delivery of implant with catheter-based system<br><br> 12. Severe heart failure (New York Heart Association Class IV)<br><br> 13. Prior cardiac transplant, history of mitral valve replacement or transcatheter<br> mitral valve intervention, or any mechanical valve implant<br><br> 14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30<br> mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)<br><br> 15. Platelet count <75,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count<br> <3,000 cells/mm3<br><br> 16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device<br> materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy,<br> or the patient has contrast sensitivity that cannot be adequately pre-medicated<br><br> 17. Actively enrolled or plans to enroll in a concurrent clinical study in which the<br> active treatment arm may confound the results of this trial<br><br> 18. Unable to undergo general anesthesia<br><br> 19. Known other medical illness or known history of substance abuse that may cause<br> non-compliance with the protocol or protocol-specified medication regimen, confound<br> the data interpretation, or is associated with a life expectancy of less than 5<br> years<br><br> 20. A condition which precludes adequate transesophageal echocardiographic assessment<br><br>Echo exclusion criteria:<br><br> 1. Left atrial appendage anatomy which cannot accommodate a commercially available<br> control device or the CLAAS device per manufacturer IFU (e.g., the anatomy and<br> sizing must be appropriate for both devices to be enrolled in the trial)<br><br> 2. Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus,<br> as visualized by TEE prior to implant<br><br> 3. Left ventricular ejection fraction (LVEF) <30%<br><br> 4. Moderate or large circumferential pericardial effusion >10 mm or symptomatic<br> pericardial effusion, signs or symptoms of acute or chronic pericarditis, or<br> evidence of tamponade physiology<br><br> 5. Atrial septal defect that warrants closure<br><br> 6. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm<br> (excursion >15 mm or length > 15 mm) or large shunt (early [within 3 beats] and/or<br> substantial passage of bubbles, e.g., >20)<br><br> 7. Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)<br><br> 8. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch<br><br> 9. Evidence of cardiac tumor

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedure-related complications, all-cause death, major bleeding;Ischemic stroke and systemic embolism

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality;Myocardial Infarction;Neurologic Events;Closure Success