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

This study has been terminated.
Sponsor:
Information provided by:
Biosense Webster EMEA
ClinicalTrials.gov Identifier:
NCT00227344
First received: September 15, 2005
Last updated: April 6, 2010
Last verified: April 2010
History of Changes
  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: Drug therapy
 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:

U.S. FDA Resources

Further study details as provided by Biosense Webster EMEA:

Primary Outcome Measures:
  • Absence of persistent atrial tachyarrhythmias relapse during the first 24 months after the run-in phase (2 months). [ Time Frame: 26 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total absence of any documented atrial tachyarrhythmias lasting longer than 30 secs during the first 24 months after the run-in phase [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Procedural success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Time to first recurrence of any tachyarrhythmias [ Time Frame: during 24 Months after run-in phase (2 months) ] [ Designated as safety issue: No ]
  • Clinical success in association with antiarrhythmic drugs [ Time Frame: 26 Months & at each patient's last follow-up visit ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 14, 26 & 38 Months ] [ Designated as safety issue: No ]
  • Health-economics Parameters, including days of hospitalization. [ Time Frame: 26 Months & at each patient's last follow-up visit ] [ Designated as safety issue: No ]
  • Sinus rhythm at the last follow-up visit, measured by ECG and 24h Holter monitor. [ Time Frame: at each patient's last follow-up visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: December 2004
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Catheter Ablation
 Device: RF ablation
Catheter ablation with NAVISTAR® THERMOCOOL® Catheter
Active Comparator: 2
Drug treatment
 Drug: Drug therapy
Antiarrhythmic drugs

  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
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
St. Mary's 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
Principal Investigator: Caetano Senatore, MD Azienda Sanitaria Locale n. 6, Cirie (TO), Italy
  More Information

No publications provided

Responsible Party: Biosense Webster EMEA
ClinicalTrials.gov Identifier: NCT00227344     History of Changes
Other Study ID Numbers: CACAF2
Study First Received: September 15, 2005
Last Updated: April 6, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013