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Non-valvular Atrial FibrillationNCT03616028

The CONFORMAL Early Feasibility Study

A study testing left atrial appendage closure in people with Non-valvular Atrial Fibrillation, run by Conformal Medical, Inc at 11 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Non-valvular Atrial Fibrillation
What is being tested?
left atrial appendage closure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
11 sitesUnited States
Study dates
22 Feb 2019to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 39Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Texas Cardiac Arrhythmia Institute

    Austin, Texas, 78705

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

  • Baylor Scott & white Research Institute

    Plano, Texas, 75093

  • Pacific Heart Institute

    Santa Monica, California, 90404

  • Lankenau Heart Institute

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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

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

Read the 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.

Being tested
left atrial appendage closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • left atrial appendage closureDevice

    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

Study groups in NCT03616028
Study groupRoleWhat they receive
Non-valvular AF adultsExperimentalLeft 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.
Receives: Device: left atrial appendage closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 45 days

Secondary outcomes (2)

  1. Closure success

    Device success followed by complete closure or peri-device residual leak ,/= 5mm in width on TEE (evaluated by independent core lab)

    Measured: 45 days post procedure, 6 months, 12 months

  2. Major Adverse Events

    All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.

    Measured: 1year, 2 years, 3 years, 4 years, 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start22 Feb 2019
  3. Primary completion27 May 2022
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03616028
Sponsor's protocol ID
18-101
Status last verified
Feb 2026
First submitted
30 Jul 2018
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing left atrial appendage closure in people with Non-valvular Atrial Fibrillation, run by Conformal Medical, Inc at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from major adverse events: (time frame: up to 45 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03616028.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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