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Completed

NCT Number: NCT00560885

AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mercy Heart Institute, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AtriCure Bipolar System

Device

Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Primary outcomes

  1. 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

  2. Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge

    Time frame: 30 days Post Procedure

    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 outcomes

  1. 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

  2. Composite 6-month Post-procedure Major Adverse Event Rate.

    Time frame: 6 Months Post Procedure

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study title

AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Acronym: ABLATE

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Nov 20, 2007
Registry last updated
Mar 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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