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Stroke Feasibility Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AtriCure, Inc.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01997905
First received: November 21, 2013
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
AFib
Device: AtriClip LAA Exclusion Device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • Serious Adverse Events within 30 Days Post-Index Procedure [ Time Frame: 30 days post-index procedure ] [ Designated as safety issue: Yes ]

    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).

  • Composite Left Atrial Appendage Placement and Exclusion success [ Time Frame: Immediate to 3-months post-index procedure ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Rate of Stroke and Non-CNS systemic embolism [ Time Frame: 3 months and 6 months post-index procedure ] [ Designated as safety issue: Yes ]

    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.

  • Serious Device or Procedure Related Adverse Event Rate [ Time Frame: 3 month and 6 month post-index procedure ] [ Designated as safety issue: Yes ]
    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.

  • Overall Serious Adverse Event Rate [ Time Frame: 3 month and 6 month Post Index Procedure ] [ Designated as safety issue: Yes ]
    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.

  • Overall Adverse Event Rate [ Time Frame: 3 month and 6 month post-index procedure ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AtriClip LAA Exclusion Device
AtriClip delivered via minimally invasive surgical procedure
Device: AtriClip LAA Exclusion Device
Other Names:
  • LAAØ
  • PRO1
  • AtriClip™ LAA Exclusion System
  • AtriClip™ LAA Exclusion System w/ preloaded Gillinov-Cosgrove™ Clip
  • AtriClip LAA Exclusion System and Delivery System (LAAØ)
  • AtriClip LAA Exclusion System and Delivery System (PRO1)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is ≥ 18 years and ≤ 80 years of age.
  2. Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
  3. CHADS2 or CHA2DS2VASc score ≥2.
  4. 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;
    • HAS-BLED Score ≥ 3.
  5. Patient is considered an acceptable surgical candidate, including use of general anesthesia.
  6. Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.

Exclusion Criteria:

  1. Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure.
  2. Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax.
  3. Myocardial infarction within 60 days prior to index procedure.
  4. NYHA Class IV heart failure.
  5. Ejection fraction < 40% (based on baseline transthoracic echocardiography (TTE)).
  6. Prior attempted obliteration of left atrial appendage (percutaneous or open cardiac surgery).
  7. Previous catheter ablation with perforation or complication.
  8. Prior open cardiac surgery, or percutaneous coronary intervention with associated unintended cardiac perforation, or pericardial adhesions are suspected.
  9. History of pericarditis or pericardiocentesis.
  10. Active infection, septicemia, or fever of unknown origin.
  11. Concomitant elective surgical procedure (in addition to AtriClip placement) at the time of index procedure.
  12. Planned atrial arrhythmia ablation procedure within six months following index procedure.
  13. Underlying structural heart disease requiring planned surgical treatment within six months following the index procedure.
  14. Cardiac or thoracic surgical procedure within the thirty days prior to index procedure.
  15. Anticoagulation therapy for other medical condition (i.e. deep vein thrombosis) is required.
  16. 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.
  17. Renal Failure as defined by creatinine > 2.0 mg/dl (> 152.5 umol/L) and/or need for dialysis.
  18. Known carotid artery diameter stenosis greater than 80%.
  19. Patient has symptomatic or high-grade carotid disease (>70% bilaterally).
  20. Patient unable or unwilling to undergo transesophageal echocardiography (TEE).
  21. Presence of thrombus in the left atrium or LAA, as determined by baseline TTE or Computed Tomography Angiogram (CTA).
  22. Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
  23. Moderate to Severe Chronic Obstructive Pulmonary Disease (FEV1 or VC<70% predicted) or intolerant of single lung ventilation.
  24. History of Hypercoagulopathy
  25. Body Mass Index (BMI) > 35.
  26. 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).
  27. Enrolled in another investigational device or drug study at the time of enrollment and during the course of the study.
  28. Psychiatric disorder which in the judgment of the investigator could interfere with informed consent, completion of tests, therapy, or follow-up.
  29. Patient is pregnant or intends to become pregnant within 6 months post-index procedure.

Intraoperative Exclusion Criteria

  1. Left atrial appendage width < 29mm or > 50mm, based on TEE imaging.
  2. Presence of thrombus in the left atrium or LAA based on TEE imaging.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997905

Contacts
Contact: Shana Zink 513-755-4562 szink@atricure.com

Locations
United States, Florida
Mercy Hospital Recruiting
Miami, Florida, United States, 33133
Contact: Saqib Masroor         
Contact: John Morgan    305-285-2792    John.Morgan@hcahealthcare.com   
United States, Indiana
Franciscan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Marc Gerdisch         
Contact: Molly Miller    317-893-1948    Molly.Miller@franciscanalliance.org   
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: J. Michael Smith         
Contact: Carol Krabbe    513-862-2877    carol_krabbe@trihealth.com   
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Basel Ramlawi         
Contact: Jonathan Wiese    713-441-7161    jrwiese@houstonmethodist.org   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Gorav Ailawadi         
Contact: J. Michael Cosner    434-982-6003 PIC #3523    JMC2CM@hscmail.mcc.virginia.edu   
United States, Wisconsin
Aspirus Recruiting
Wausau, Wisconsin, United States, 54401
Contact: John Johnkoski         
Contact: Megan Johnson    715-847-2000, ext. 50160    Megan.Johnson@aspirus.org   
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: Basel Ramlawi, MD Methodist Hospital Houston
  More Information

No publications provided

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01997905     History of Changes
Other Study ID Numbers: CP2011-2
Study First Received: November 21, 2013
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:
Atrial Fibrillation
Left Atrial Appendage
LAA
AFib
AF
IRB approved
clinical
Stroke
TIA
contraindication to oral anticoagulation therapy
Arrhythmias, Cardiac
OAC
trial
study
LAA occlusion
occluded

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014