The CONFORMAL Early Feasibility Study

• ClinicalTrials.gov Identifier: NCT03616028
• Recruitment Status: Recruiting
• First Posted: August 6, 2018
• Last Update Posted: July 1, 2019
• Sponsor: Conformal Medical, Inc
• Collaborator: Yale Cardiovascular Research Group
• Information provided by (Responsible Party): Conformal Medical, Inc

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Non-valvular Atrial Fibrillation	Device: left atrial appendage closure	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a prospective, multicenter, open-label, first-in-human study aimed at examining the performance of the CLAAS device for LAA closure.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• 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
• Actual Study Start Date: February 22, 2019
• Estimated Primary Completion Date: April 2020
• Estimated Study Completion Date: June 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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

Outcome Measures

Primary Outcome Measures :

1. Freedom from major adverse events: [ Time Frame: up to 45 days ]
   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.

Secondary Outcome Measures :

1. Closure success [ Time Frame: 45 days post procedure, 6 months, 12 months ]
   Device success followed by complete closure or peri-device residual leak ,/= 5mm in width on TEE (evaluated by independent core lab)
2. Major Adverse Events [ Time Frame: 1year, 2 years, 3 years, 4 years, 5 years ]
   All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

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

Contacts and Locations

Contacts

Contact: Chris Cain, BSN; 408-439-5154; ccain@conformalmedical.com

Locations

United States, New Hampshire

Catholic Medical Center; Recruiting

Manchester, New Hampshire, United States, 03102

Contact: Elizabeth Cornelius, RN elizabeth.cornelius@cmc-nh.org

Principal Investigator: Jamie Kim, M.D.

United States, New York

Columbia University Medical Center/NYPH; Recruiting

New York, New York, United States, 10032

Contact: Efrain DeJesus efd2116@cumc.columbia.edu

Principal Investigator: Robert Sommer, M.D.

United States, Pennsylvania

Bryn Mawr Hospital; Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

Contact: Lisa Thome, MS ThomeL@mlhs.org

Principal Investigator: Sheetal Chandhok, M.D.

United States, Texas

The Heart Hospital Baylor Plano; Recruiting

Plano, Texas, United States, 75093

Contact: Gina Ortiz gina.ortiz@bswhealth.org

Principal Investigator: Molly Szerlip, M.D.

Sponsors and Collaborators

Conformal Medical, Inc

Yale Cardiovascular Research Group

Investigators

• Principal Investigator: William A Gray, MD; Main Line Health Lankenae Heart Institute

More Information

• Responsible Party: Conformal Medical, Inc
• ClinicalTrials.gov Identifier: NCT03616028
• Other Study ID Numbers: 18-101
• First Posted: August 6, 2018
• Last Update Posted: July 1, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes