Catheter Ablation for Cure of Atrial Fibrillation
Overview
- Phase
- Phase 4
- Intervention
- RF ablation
- Conditions
- Atrial Fibrillation
- Sponsor
- Biosense Webster EMEA
- Enrollment
- 129
- Primary Endpoint
- Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18-70 years
- •Written informed consent
- •One documented relapse of atrial fibrillation (AF) during antiarrhythmic drug therapy after an electrical cardioversion
Exclusion Criteria
- •Permanent atrial fibrillation
- •Patients who had tried \>1 antiarrhythmic drug (Class I or Class III).
- •AF was the sole rhythm for \>6 months before the enrollment.
- •Previous ablation for AF.
- •AF is deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy.
- •Patients who have fibrillation episodes triggered by another uniform arrhythmia (eg, atrial flutter or atrial tachycardia).
- •Patients with intra-atrial thrombus, tumor, or another abnormality that precludes catheter introduction.
- •Patients with Wolf-Parkinson-White syndrome.
- •Patients awaiting cardiac transplantation.
- •Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-III-IV or ejection fraction (EF) \<40%.
Arms & Interventions
1
Catheter ablation
Intervention: RF ablation
2
Antiarrhythmic drugs
Intervention: Antiarrhythmic drugs
Outcomes
Primary Outcomes
Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
Time Frame: within first 24 months after a 2-month run-in phase
Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions.
Secondary Outcomes
- Quality of Life(at 14, 26 and 38 months)
- Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase(day 61 through 790)
- Health-economics Parameters (Days of Hospitalization)(at 26 months and at each patients last follow-up visit)
- Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor(at each patients last follow-up visit)
- Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months)(within first 24 months after a 2-month run-in phase)
- Percentage of Procedural Success(The day of the procedure)
- Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs(at 26 months and at each patients last follow-up visit)