- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03616028
The CONFORMAL Early Feasibility Study
February 28, 2024 updated by: Conformal Medical, Inc
The CONFORMAL Early Feasibility Study An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- St. Bernards Medical Center
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California
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Santa Monica, California, United States, 90404
- Pacific Heart Institute
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New Hampshire
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Manchester, New Hampshire, United States, 03102
- Catholic Medical Center
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New York
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New York, New York, United States, 10029
- Mount Sinai
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New York, New York, United States, 10032
- Columbia University Medical Center/NYPH
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Ohio
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Cincinnati, Ohio, United States, 45219
- The Christ Hospital
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Pennsylvania
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Heart Institute
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Erlanger Health System
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Texas
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Austin, Texas, United States, 78705
- Texas Cardiac Arrhythmia Institute
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Plano, Texas, United States, 75093
- Baylor Scott & White Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male or non-pregnant female aged ≥18 years
- Documented non-valvular AF (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women
- The patient is recommended for oral anticoagulation therapy (OAC), but has an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
- 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.
- The patient is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations
- 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
- 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.
- 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)
- 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)
- 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)
- History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
- Active infection with bacteremia
- Documented symptomatic carotid artery disease (>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of >70%)
- Recent (within 30 days pre-procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure
- Recent (within 90 days pre-procedure) stroke or transient ischemic attack.
- Recent (within 60 days pre-procedure) myocardial infarction
- Vascular access precluding delivery of implant with catheter-based system
- Severe heart failure (New York Heart Association Class III or IV)
- Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
- 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
- Platelet count <75,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3
- 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
- Current participation in another investigational drug or device study
- Patient is a prisoner
- Patient is unable to undergo general anesthesia
- 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
- Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
Echocardiographic Exclusion Criteria
- Left atrial appendage anatomy cannot accommodate the CLAAS device per manufacturer IFU
- Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
- Left ventricular ejection fraction (LVEF) <30%
- Circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
- Atrial septal defect that warrants closure
- 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)
- Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
- Complex atheroma with mobile plaque of the aorta
- Patient has evidence of cardiac tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from major adverse events:
Time Frame: up to 45 days
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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.
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up to 45 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Closure success
Time Frame: 45 days post procedure, 6 months, 12 months
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Device success followed by complete closure or peri-device residual leak ,/= 5mm in width on TEE (evaluated by independent core lab)
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45 days post procedure, 6 months, 12 months
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Major Adverse Events
Time Frame: 1year, 2 years, 3 years, 4 years, 5 years
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All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.
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1year, 2 years, 3 years, 4 years, 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William A Gray, MD, Main Line Health Lankenae Heart Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2019
Primary Completion (Actual)
May 27, 2022
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
July 30, 2018
First Submitted That Met QC Criteria
August 2, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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