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NCT Number: NCT00431834

Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat permanent AF patients.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southwest Heart and Lung, Phoenix, Arizona, 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

  • Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines.
  • Concomitant indication (other than AF) for open-heart surgery for one or more of the following:
  • Mitral valve repair or replacement
  • Aortic valve repair or replacement
  • Tricuspid valve repair or replacement
  • Atrial septal defect (ASD) repair
  • Patent foramen ovale (PFO) closure
  • Coronary artery bypass procedures
  • Greater than or equal to 18 years of age
  • Able and willing to comply with study requirements by signing a consent form
  • Must be able to take the anticoagulant warfarin (Coumadin)

Exclusion criteria

  • Wolff-Parkinson-White syndrome
  • NYHA Class = IV
  • Left ventricular ejection fraction ≤ 30%
  • Need for emergent cardiac surgery (i.e. cardiogenic shock)
  • Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze procedure
  • Contraindication for anticoagulation therapy
  • Left atrial diameter > 7.0 cm
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  • Renal failure requiring dialysis or hepatic failure
  • Life expectancy of less than one year
  • Pregnancy or desire to be pregnant within 12 months of the study treatment.
  • Current diagnosis of active systemic infection
  • Documented MI 6 weeks prior to study enrollment

Treatment and study plan

Cardioblate System Surgical Ablation System

Device

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.

Surgical RF Ablation

Procedure

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.

Primary outcomes

  1. Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.

    Time frame: 6 months

    Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.

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

    Time frame: 30 days post procedure or hospital discharge

    Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.

Secondary outcomes

  1. Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 6 Months

    Time frame: 6 months

  2. Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure

    Time frame: 6 months

    Major Adverse Events included: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study title

Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent Study

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Feb 6, 2007
Registry last updated
Nov 27, 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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