Phase 3
N=55
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00560885 ↗Enrolled (actual)
55
Serious AEs
81.8%
Results posted
Mar 2013
Primary outcome: Primary: Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. — 74 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AtriCure Bipolar System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Free From AF and Off Class I and III Anti-arrhythmic Drugs as Determined by Holter Monitoring at 6 Months. |
74 | — |
| PRIMARY Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge |
9.1 | — |
| SECONDARY Percent of Patients Free From AF, Independent of Antiarrhythmic Drug Status as Determined by Holter Monitoring at 6 Months. |
84 | — |
| SECONDARY Composite 6-month Post-procedure Major Adverse Event Rate. |
10.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00560885). 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.