CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation

Phase 4

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: RF ablation; Drug: Antiarrhythmic drugs

• Registration Number: NCT00227344
• Lead Sponsor: Biosense Webster EMEA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-28
• Primary Completion: 2008-10
• Study Completion: 2009-05
• Results First Submitted: 2014-05-27
• Results First Submitted QC: 2015-01-05
• Results First Posted: 2015-01-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RF ablation	Catheter ablation
2	Antiarrhythmic drugs	Antiarrhythmic drugs

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).	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 Outcome Measures

Name	Time	Method
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase	day 61 through 790
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	Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following: 1. "Has a validation of the lesions been performed by taking 3 points inside each circular lesion?"; 2. "If YES to #1, did you observe that none of them exceed 0.1 mV?"; 3. "Did you observe any adverse event during the procedure?"; If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success.
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
Quality of Life	at 14, 26 and 38 months
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

Trial Locations

Locations (12)

Casa di Cura Villa Maria Cecilia; 🇮🇹 Cotignola, Italy

Ospedale Morgagni; 🇮🇹 Florence, Italy

ULSS no. 10; 🇮🇹 Treviso (VE), Italy

ASL no. 6; 🇮🇹 Cirie (TO), Italy

Casa di Cura San Michele; 🇮🇹 Maddaloni, Italy

Heart hospital; 🇬🇧 London, United Kingdom

Az. Osp. di Ferrara- Arcispedale Sant'Anna; 🇮🇹 Ferrara, Italy

ULSS no. 13; 🇮🇹 Mirano (VE), Italy

Ospedale San Eugenio; 🇮🇹 Rome, Italy

Oulu Hospital; 🇫🇮 Oulu, Finland

Az. ULSS no. 15 Alta Padovana; 🇮🇹 Camposampiero (VE), Italy

Az. Provinciale per I Serv. Sanit.; 🇮🇹 Trento, Italy