Clinical trial NCT00227344: CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation
Official title: Catheter Ablation for Cure of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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%.
* Patients with unstable angina or acute myocardial infarction within 3 months.
* Patients with cardiac revascularization or other cardiac surgery within 6 months.
* Patients with heart disease in which corrective surgery is anticipated.
* Patients in whom appropriate vascular access is precluded.
* Pregnant women.
* A separate requirement for antiarrhythmic drug treatment, which will require an antiarrhythmic drug not previously tried for AF suppression.
* Prior atrial surgery.
* Contraindication to treatment with warfarin or other bleeding diathesis.
* Renal failure requiring dialysis.
* Hepatic failure.
* Participant in investigational clinical or device trial.
* Unwilling or unable to give informed consent.
* Inaccessible for follow-up.
* Psychological problem that might limit compliance.
* Active abuse of alcohol or other drugs which may be causative of AF.
* An implanted device (pacemaker or cardioverter-defibrillator).
* Left atrial diameter (anteroposterior) \>50 mm.

Primary outcomes:
measure: Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
timeFrame: within first 24 months after a 2-month run-in phase
Secondary outcomes:
measure: 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)
timeFrame: within first 24 months after a 2-month run-in phase
measure: Percentage of Procedural Success
timeFrame: The day of the procedure
measure: Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
timeFrame: day 61 through 790
measure: Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs
timeFrame: at 26 months and at each patients last follow-up visit
measure: Quality of Life
timeFrame: at 14, 26 and 38 months
measure: Health-economics Parameters (Days of Hospitalization)
timeFrame: at 26 months and at each patients last follow-up visit
measure: Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor
timeFrame: at each patients last follow-up visit
Other outcomes:
Locations:
Study officials:
affiliation: ULSS n.13, Mirano (VE), Italy
name: Emanuele Bertaglia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Casa di Cura San Michele, Maddaloni, Italy
name: Giuseppe Stabile, MD
role: PRINCIPAL_INVESTIGATOR
References: