CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— CACAF-2  

Official title:

Catheter Ablation for Cure of Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00227344
• Other study ID #: CACAF2
• Status: Terminated
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: January 5, 2015
• Start date: December 2004
• Est. completion date: May 2009

Study information

• Verified date: January 2015
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeItaly: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 129
• Est. completion date: May 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Finland	Oulu Hospital	Oulu
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)
United Kingdom	Heart hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster EMEA

Countries where clinical trial is conducted

Finland,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase		day 61 through 790	No
Secondary	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	No
Secondary	Quality of Life		at 14, 26 and 38 months	No
Secondary	Health-economics Parameters (Days of Hospitalization)		at 26 months and at each patients last follow-up visit	No
Secondary	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	No