CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation (CACAF-2)

Catheter Ablation for Cure of Atrial Fibrillation

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: RF ablation; Drug: Antiarrhythmic drugs

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland
    • Oulu Hospital
• Italy
  • Camposampiero (VE), Italy
    • Az. ULSS no. 15 Alta Padovana
  • Cirie (TO), Italy
    • ASL no. 6
  • Cotignola, Italy
    • Casa di Cura Villa Maria Cecilia
  • Ferrara, Italy
    • Az. Osp. di Ferrara- Arcispedale Sant'Anna
  • Florence, Italy
    • Ospedale Morgagni
  • Maddaloni, Italy
    • Casa di Cura San Michele
  • Mirano (VE), Italy
    • ULSS no. 13
  • Rome, Italy
    • Ospedale San Eugenio
  • Trento, Italy
    • Az. Provinciale per I Serv. Sanit.
  • Treviso (VE), Italy
    • ULSS no. 10
• United Kingdom
  • London, United Kingdom
    • Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Catheter ablation	Device: RF ablation; Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System
Active Comparator: 2; Antiarrhythmic drugs	Drug: Antiarrhythmic drugs; Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).	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.	within first 24 months after a 2-month run-in phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following: "Has a validation of the lesions been performed by taking 3 points inside each circular lesion?"; "If YES to #1, did you observe that none of them exceed 0.1 mV?"; "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.	The day of the procedure
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase		day 61 through 790
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

Collaborators and Investigators

• Sponsor: Biosense Webster EMEA
• Investigators: Principal Investigator: Emanuele Bertaglia, MD, ULSS n.13, Mirano (VE), Italy; Principal Investigator: Giuseppe Stabile, MD, Casa di Cura San Michele, Maddaloni, Italy

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 15, 2005
• First Submitted That Met QC Criteria: September 27, 2005
• First Posted (Estimate): September 28, 2005

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anti-Arrhythmia Agents
• Other Study ID Numbers: CACAF2