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The CONFORMAL Early Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616028
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
Yale Cardiovascular Research Group
Information provided by (Responsible Party):
Conformal Medical, Inc

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.

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616028


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

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

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Responsible Party: Conformal Medical, Inc
ClinicalTrials.gov Identifier: NCT03616028    
Other Study ID Numbers: 18-101
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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