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AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE)

Primary Purpose

Atrial Fibrillation

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

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, af, ablation, arrhythmia, racing heart, afib, surgical ablation

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 permanent 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
    • Atrial Septal Defect Repair
    • Patent Foramen Ovale closure
  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. Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
  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 8cm
  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

  • Mercy Heart Institute
  • Sutter Health
  • Heart Center of Indiana
  • Spectrum Health
  • Munson Medical Center
  • Baylor Heart Hospital
  • Inova Fairfax
  • Sentara Norfolk General Hospital
  • Carilion Roanoke Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AtriCure Bipolar System

Arm Description

The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.

Outcomes

Primary Outcome Measures

Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.

Secondary Outcome Measures

Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
Composite 6-month Post-procedure Major Adverse Event Rate.

Full Information

First Posted
November 19, 2007
Last Updated
March 20, 2013
Sponsor
AtriCure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00560885
Brief Title
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
Acronym
ABLATE
Official Title
AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent 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
Keywords
atrial fibrillation, af, ablation, arrhythmia, racing heart, afib, surgical ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AtriCure Bipolar System
Arm Type
Experimental
Arm Description
The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.
Intervention Type
Device
Intervention Name(s)
AtriCure Bipolar System
Intervention Description
Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Primary Outcome Measure Information:
Title
Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months.
Time Frame
6 Months Post Procedure
Title
Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
Description
Major Adverse Events consist of Death within 30 days or beyond 30 days if considered device related, Excessive Bleeding, Stroke, TIA or MI. A clinic visist was performed at 30 days to fully assess the patient for adverse events.
Time Frame
30 days Post Procedure
Secondary Outcome Measure Information:
Title
Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months.
Time Frame
6 Months Post Procedure
Title
Composite 6-month Post-procedure Major Adverse Event Rate.
Time Frame
6 Months Post Procedure

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 permanent 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 Atrial Septal Defect Repair Patent Foramen Ovale closure 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: Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure 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 8cm 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
Facility Information:
Facility Name
Mercy Heart Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Sutter Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Baylor Heart Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Inova Fairfax
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

Learn more about this trial

AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

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