The CONFORMAL Early Feasibility Study

Non-valvular Atrial Fibrillation Clinical Trial

Official title:

The CONFORMAL Early Feasibility Study An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03616028
• Other study ID #: 18-101
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: June 2025

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 2025
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 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)

General 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

Echocardiographic Exclusion Criteria

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute	Austin	Texas
United States	Erlanger Health System	Chattanooga	Tennessee
United States	The Christ Hospital	Cincinnati	Ohio
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center/NYPH	New York	New York
United States	Mount Sinai	New York	New York
United States	Baylor Scott & white Research Institute	Plano	Texas
United States	Pacific Heart Institute	Santa Monica	California
United States	Lankenau Heart Institute	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Conformal Medical, Inc	Yale Cardiovascular Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse events:	Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.	up to 45 days
Secondary	Closure success	Device success followed by complete closure or peri-device residual leak ,/= 5mm in width on TEE (evaluated by independent core lab)	45 days post procedure, 6 months, 12 months
Secondary	Major Adverse Events	All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.	1year, 2 years, 3 years, 4 years, 5 years