CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation

NCT00227344 | Terminated Phase 4 Results

• 1 other identifier: CACAF2
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Catheter ablation

Device: RF ablation

2

ACTIVE COMPARATOR

Antiarrhythmic drugs

Drug: Antiarrhythmic drugs

Interventions

RF ablation DEVICE

Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System

1

Antiarrhythmic drugs DRUG

Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Written informed consent
• One documented relapse of atrial fibrillation (AF) during antiarrhythmic drug therapy after an electrical cardioversion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosense Webster EMEA: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

The study was terminated early due to randomization imbalance. The relatively small number of subjects enrolled limited the amount of data available for analysis. Because the study did not reach its targeted enrollment, the study is underpowered.

Results Point of Contact

• Title: Pat Ticknor, Clinical Operations
• Organization: Biosense Webster, Inc.

PTicknor@its.jnj.com

909-839-8500

Study Officials

• Emanuele Bertaglia, MD

  ULSS n.13, Mirano (VE), Italy

  PRINCIPAL INVESTIGATOR

• Giuseppe Stabile, MD

  Casa di Cura San Michele, Maddaloni, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 28, 2005
• Study Start: December 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: May 1, 2009
• Last Updated: February 4, 2025
• Results First Posted: January 14, 2015

Record last verified: 2025-01