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Atrial FibrillationPhase 1/2NCT01997905

Stroke Feasibility Study

A Phase 1/2 study testing AtriClip LAA Exclusion Device in people with Atrial Fibrillation and AFib, run by AtriCure, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation, AFib
What is being tested?
AtriClip LAA Exclusion Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
7 sitesUnited States
Study dates
Jan 2014to Aug 2015
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is ≥ 18 years and ≤ 80 years of age.
  • Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
  • CHADS2 or CHA2DS2VASc score ≥2.
  • Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following:
  • history of intracranial bleeding (e.g. due to amyloid angiopathy or other condition) which renders patient unsafe for OAC;
  • history of gastrointestinal, genitourinary, or respiratory tract bleeding due to permanent condition which renders patient unsafe for OAC;
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  • HAS-BLED Score ≥ 3.
  • Patient is considered an acceptable surgical candidate, including use of general anesthesia.
  • Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.

Who cannot join

  • Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure.
  • Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax.
  • Myocardial infarction within 60 days prior to index procedure.
  • NYHA Class IV heart failure.
  • Ejection fraction < 40% (based on baseline transthoracic echocardiography (TTE)).
  • Prior attempted obliteration of left atrial appendage (percutaneous or open cardiac surgery).
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  • Previous catheter ablation with perforation or complication.
  • Prior open cardiac surgery, or percutaneous coronary intervention with associated unintended cardiac perforation, or pericardial adhesions are suspected.
  • History of pericarditis or pericardiocentesis.
  • Active infection, septicemia, or fever of unknown origin.
  • Concomitant elective surgical procedure (in addition to AtriClip placement) at the time of index procedure.
  • Planned atrial arrhythmia ablation procedure within six months following index procedure.
  • Underlying structural heart disease requiring planned surgical treatment within six months following the index procedure.
  • Cardiac or thoracic surgical procedure within the thirty days prior to index procedure.
  • Anticoagulation therapy for other medical condition (i.e. deep vein thrombosis) is required.
  • Patient unable to discontinue thienopyridines (e.g. clopidogrel) or non-ASA antiplatelet agents 4 days pre-operatively and abstain for at least 2 days post-operatively.
  • Renal Failure as defined by creatinine > 2.0 mg/dl (> 152.5 umol/L) and/or need for dialysis.
  • Known carotid artery diameter stenosis greater than 80%.
  • Patient has symptomatic or high-grade carotid disease (>70% bilaterally).
  • Patient unable or unwilling to undergo transesophageal echocardiography (TEE).
  • Presence of thrombus in the left atrium or LAA, as determined by baseline TTE or Computed Tomography Angiogram (CTA).
  • Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
  • Moderate to Severe Chronic Obstructive Pulmonary Disease (FEV1 or VC<70% predicted) or intolerant of single lung ventilation.
  • History of Hypercoagulopathy
  • Body Mass Index (BMI) > 35.
  • Other medical illness or comorbidity that may cause non-compliance with the protocol, confound data interpretation (e.g. severe dementia), or limited life expectancy (i.e. < 3 months).
  • Enrolled in another investigational device or drug study at the time of enrollment and during the course of the study.
  • Psychiatric disorder which in the judgment of the investigator could interfere with informed consent, completion of tests, therapy, or follow-up.
  • Patient is pregnant or intends to become pregnant within 6 months post-index procedure.
  • Intraoperative Exclusion Criteria
  • Left atrial appendage width < 29mm or > 50mm, based on TEE imaging.
  • Presence of thrombus in the left atrium or LAA based on TEE imaging.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • Mercy Hospital

    Miami, Florida, 33133

  • St. Helena Hospital

    St. Helena, California, 94574

  • Aspirus

    Wausau, Wisconsin, 54401

Other trials in United States

About this study

Official title: Feasibility Clinical Investigation of a Minimally Invasive Surgically Deployed AtriCure AtriClip Left Atrial Appendage Exclusion System for Stroke Prophylaxis in Patients With Non-Valvular Atrial Fibrillation and in Whom Long Term Oral Anticoagulation Therapy is Medically Contraindicated

This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.

Being tested
AtriClip LAA Exclusion Device
Keywords
Left Atrial Appendage, LAA, Atrial Fibrillation, AFib, AF, IRB approved, clinical, Stroke, TIA, contraindication to oral anticoagulation therapy, Arrhythmias, Cardiac, OAC, trial, study, LAA occlusion, occluded, prevent
Medical subject headings
Atrial Fibrillation, Stroke, Arrhythmias, Cardiac, Bites and Stings

What participants receive

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

  • AtriClip LAA Exclusion DeviceDevice

    Also called LAAØ, PRO1, AtriClip™ LAA Exclusion System, AtriClip™ LAA Exclusion System w/ preloaded Gillinov-Cosgrove™ Clip

Study groups in NCT01997905
Study groupRoleWhat they receive
AtriClip LAA Exclusion DeviceExperimentalAtriClip delivered via minimally invasive surgical procedure
Receives: Device: AtriClip LAA Exclusion Device

What is being measured

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

  1. Number of Serious Adverse Events Within 30 Days Post-Index Procedure

    The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator:

    • Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip
    • Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke
    • Major bleeding (defined as requiring re-operation and/or transfusion (> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure).

    Measured: 30 days post-index procedure

  2. Composite Left Atrial Appendage Placement and Exclusion Success

    Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:

    1. Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.
    2. Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and <10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE.
    3. 3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and < 10mm residual pocket) between the LA and LAA at >=3 month TEE or CTA evaluation.

    Measured: Immediate to 3-months post-index procedure

Secondary outcomes (4)

  1. Rate of Stroke and Non-CNS Systemic Embolism

    The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure:

    1. Stroke (ischemic )
    2. Non-CNS (Central Nervous System) systemic embolism.

    Measured: 3 months and 6 months post-index procedure

  2. Serious Device or Procedure Related Adverse Event Rate

    Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.

    Measured: 3 month and 6 month post-index procedure

  3. Overall Serious Adverse Event Rate

    Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.

    Measured: 3 month and 6 month Post Index Procedure

  4. Overall Adverse Event Rate

    Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.

    Measured: 3 month and 6 month post-index procedure

Timeline

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

  1. First posted28 Nov 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2015
  4. Study completionAug 2015

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01997905
Sponsor's protocol ID
CP2011-2
Status last verified
Oct 2016
First submitted
21 Nov 2013
Last updated
14 Dec 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AtriClip LAA Exclusion Device in people with Atrial Fibrillation and AFib, run by AtriCure, Inc. at 7 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 9 inclusion and 32 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: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Serious Adverse Events Within 30 Days Post-Index Procedure (time frame: 30 days post-index procedure). The study lists 2 primary outcomes in all. 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 NCT01997905.

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 14 Dec 2016.

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