Phase 3
N=75
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00431834 ↗Enrolled (actual)
75
Serious AEs
61.3%
Results posted
Oct 2013
Primary outcome: Primary: 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. — 37.7 percentage of participants — p=<0.0041
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cardioblate System Surgical Ablation System (Device); Surgical RF Ablation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiovascular
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
37.7 | <0.0041 sig |
| PRIMARY Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge |
5.3 | <0.0001 sig |
| SECONDARY 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 |
63.9 | — |
| SECONDARY Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure |
8.7 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00431834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.