The CONFORMAL Early Feasibility Study

NCT ID: NCT03616028

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-22
• Study Completion Date: 2028-06-30

Brief Summary

An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Detailed Description

The Conformal Left Atrial Appendage Seal (CLAAS) Device is a permanent implant designed to occlude the left atrial appendage (LAA) to eliminate blood flow into and clot passage from the LAA.

Conditions

Non-valvular Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Non-valvular AF adults

Left atrial appendage closure (LAAC) with the CLAAS device will be performed according to the device Instructions for Use, based on TEE, ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing.

Group Type: EXPERIMENTAL

left atrial appendage closure

Intervention Type: DEVICE

Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the CLAAS device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing

Interventions

left atrial appendage closure

Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the CLAAS device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing

Intervention Type: DEVICE

Eligibility Criteria

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 CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women

4. The patient is recommended for oral anticoagulation therapy (OAC), but has an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation

5. The patient deemed appropriate for LAA closure by the Site P.I. and a non-interventional physician using an evidenced-based decision-making tool on oral anticoagulants consistent with standard of care.

6. The patient is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations

7. 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) or Ethics Committee (EC)

Exclusion Criteria

1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 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 patient 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. Patients with a medical condition (other than atrial fibrillation) that mandates chronic 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. Active infection with bacteremia

7. Documented symptomatic carotid artery disease (>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of >70%)

8. Recent (within 30 days pre-procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure

9. Recent (within 90 days pre-procedure) stroke or transient ischemic attack.

10. Recent (within 60 days pre-procedure) myocardial infarction

11. Vascular access precluding delivery of implant with catheter-based system

12. Severe heart failure (New York Heart Association Class III or 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), or dialysis at the time of screening

15. Platelet count <75,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3

16. Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium, gold) or that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated

17. Current participation in another investigational drug or device study

18. Patient is a prisoner

19. Patient is unable to undergo general anesthesia

20. 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 2 years

21. Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment

1. Left atrial appendage anatomy cannot accommodate the CLAAS device per manufacturer IFU

2. Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant

3. Left ventricular ejection fraction (LVEF) <30%

4. 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 (exclusion >15 mm or length > 15 mm) or large shunt (early [within 3 beats] or substantial passage of bubbles)

7. Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)

8. Complex atheroma with mobile plaque of the aorta

9. Patient has evidence of cardiac tumor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale Cardiovascular Research Group

OTHER

Sponsor Role: collaborator

Conformal Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William A Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health Lankenau Institute for Medical Research

Locations

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Pacific Heart Institute

Santa Monica, California, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Mount Sinai

New York, New York, United States

Columbia University Medical Center/NYPH

New York, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Lankenau Heart Institute

Wynnewood, Pennsylvania, United States

Erlanger Health System

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Institute

Austin, Texas, United States

Baylor Scott & white Research Institute

Plano, Texas, United States

Countries

United States

Other Identifiers

18-101

Identifier Type: -

Identifier Source: org_study_id