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

This study has been terminated.
(Study prematurely terminated due to randomization imbalance.)
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc. ( Biosense Webster EMEA )
ClinicalTrials.gov Identifier:
NCT00227344
First received: September 15, 2005
Last updated: January 5, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Device: RF ablation
Drug: Antiarrhythmic drugs
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation for Cure of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months). [ Time Frame: within first 24 months after a 2-month run-in phase ] [ Designated as safety issue: No ]
    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:
  • 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) [ Time Frame: within first 24 months after a 2-month run-in phase ] [ Designated as safety issue: No ]
  • Percentage of Procedural Success [ Time Frame: The day of the procedure ] [ Designated as safety issue: No ]

    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.


  • Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase [ Time Frame: day 61 through 790 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs [ Time Frame: at 26 months and at each patients last follow-up visit ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: at 14, 26 and 38 months ] [ Designated as safety issue: No ]
  • Health-economics Parameters (Days of Hospitalization) [ Time Frame: at 26 months and at each patients last follow-up visit ] [ Designated as safety issue: No ]
  • Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor [ Time Frame: at each patients last follow-up visit ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: December 2004
Study Completion Date: May 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227344

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

No publications provided

Responsible Party: Biosense Webster, Inc. ( Biosense Webster EMEA )
ClinicalTrials.gov Identifier: NCT00227344     History of Changes
Other Study ID Numbers: CACAF2
Study First Received: September 15, 2005
Results First Received: May 27, 2014
Last Updated: January 5, 2015
Health Authority: Finland: Ethics Committee
Italy: Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015