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AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation (A)

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AtriCure Bipolar System
Sponsored by
AtriCure, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is greater than or equal to 18 years of age
  2. Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines

  3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:

    • Mitral valve repair or replacement
    • Aortic valve repair or replacement
    • Tricuspid valve repair or replacement
    • Coronary Artery Bypass procedures
  4. Subject's Left Ventricular Ejection Fraction ≥ 30%
  5. Subject is able and willing to provide written informed consent and comply with study requirements
  6. Subject has life expectancy of at least 1 year

Exclusion Criteria:

  1. Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
  2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
  3. Wolff-Parkinson-White syndrome
  4. Prior cardiac surgery (Redo)
  5. Class IV NYHA heart failure symptoms
  6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
  7. Documented MI within 6 weeks prior to study enrollment
  8. Need for emergent cardiac surgery (i.e. cardiogenic shock)
  9. Known carotid artery stenosis greater than 80%
  10. LA size greater than or equal to 8 cm
  11. Current diagnosis of active systemic infection
  12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
  13. Pregnancy or desire to get pregnant within 12-months of the study enrollment
  14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  15. Renal failure requiring dialysis or hepatic failure
  16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
  17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
    The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge

    Secondary Outcome Measures

    The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
    The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.

    Full Information

    First Posted
    November 3, 2008
    Last Updated
    February 18, 2011
    Sponsor
    AtriCure, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00785902
    Brief Title
    AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
    Acronym
    A
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AtriCure, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Study Phase
    Phase 3

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    AtriCure Bipolar System
    Primary Outcome Measure Information:
    Title
    The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
    Title
    The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
    Secondary Outcome Measure Information:
    Title
    The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
    Title
    The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is greater than or equal to 18 years of age Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following: Mitral valve repair or replacement Aortic valve repair or replacement Tricuspid valve repair or replacement Coronary Artery Bypass procedures Subject's Left Ventricular Ejection Fraction ≥ 30% Subject is able and willing to provide written informed consent and comply with study requirements Subject has life expectancy of at least 1 year Exclusion Criteria: Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure Wolff-Parkinson-White syndrome Prior cardiac surgery (Redo) Class IV NYHA heart failure symptoms Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit Documented MI within 6 weeks prior to study enrollment Need for emergent cardiac surgery (i.e. cardiogenic shock) Known carotid artery stenosis greater than 80% LA size greater than or equal to 8 cm Current diagnosis of active systemic infection Severe peripheral arterial occlusive disease defined as claudication with minimal exertion Pregnancy or desire to get pregnant within 12-months of the study enrollment Preoperative need for an intra-aortic balloon pump or intravenous inotropes Renal failure requiring dialysis or hepatic failure Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders

    12. IPD Sharing Statement

    Learn more about this trial

    AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

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