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CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation

NCT00227344 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-02-04

Study results available
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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

Interventions

DEVICE

RF ablation

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

DRUG

Antiarrhythmic drugs

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

Sponsors & Collaborators

  • Biosense Webster EMEA

    lead INDUSTRY

Principal Investigators

  • Emanuele Bertaglia, MD · ULSS n.13, Mirano (VE), Italy

  • Giuseppe Stabile, MD · Casa di Cura San Michele, Maddaloni, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-10-31
Completion
2009-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00227344 on ClinicalTrials.gov