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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
RF ablation
Antiarrhythmic drugs
Sponsored by
Biosense Webster EMEA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oulu Hospital
  • Az. ULSS no. 15 Alta Padovana
  • ASL no. 6
  • Casa di Cura Villa Maria Cecilia
  • Az. Osp. di Ferrara- Arcispedale Sant'Anna
  • Ospedale Morgagni
  • Casa di Cura San Michele
  • ULSS no. 13
  • Ospedale San Eugenio
  • Az. Provinciale per I Serv. Sanit.
  • ULSS no. 10
  • Heart hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Catheter ablation

Antiarrhythmic drugs

Outcomes

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).
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)
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.
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs
Quality of Life
Health-economics Parameters (Days of Hospitalization)
Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor

Full Information

First Posted
September 15, 2005
Last Updated
March 10, 2016
Sponsor
Biosense Webster EMEA
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1. Study Identification

Unique Protocol Identification Number
NCT00227344
Brief Title
CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation
Acronym
CACAF-2
Official Title
Catheter Ablation for Cure of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Study prematurely terminated due to randomization imbalance.
Study Start Date
December 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster EMEA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Catheter ablation
Arm Title
2
Arm Type
Active Comparator
Arm Description
Antiarrhythmic drugs
Intervention Type
Device
Intervention Name(s)
RF ablation
Intervention Description
Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drugs
Intervention Description
Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
Primary Outcome Measure Information:
Title
Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months).
Description
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.
Time Frame
within first 24 months after a 2-month run-in phase
Secondary Outcome Measure Information:
Title
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
Title
Percentage of Procedural Success
Description
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.
Time Frame
The day of the procedure
Title
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
Time Frame
day 61 through 790
Title
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
Title
Quality of Life
Time Frame
at 14, 26 and 38 months
Title
Health-economics Parameters (Days of Hospitalization)
Time Frame
at 26 months and at each patients last follow-up visit
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuele Bertaglia, MD
Organizational Affiliation
ULSS n.13, Mirano (VE), Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe Stabile, MD
Organizational Affiliation
Casa di Cura San Michele, Maddaloni, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu Hospital
City
Oulu
Country
Finland
Facility Name
Az. ULSS no. 15 Alta Padovana
City
Camposampiero (VE)
Country
Italy
Facility Name
ASL no. 6
City
Cirie (TO)
Country
Italy
Facility Name
Casa di Cura Villa Maria Cecilia
City
Cotignola
Country
Italy
Facility Name
Az. Osp. di Ferrara- Arcispedale Sant'Anna
City
Ferrara
Country
Italy
Facility Name
Ospedale Morgagni
City
Florence
Country
Italy
Facility Name
Casa di Cura San Michele
City
Maddaloni
Country
Italy
Facility Name
ULSS no. 13
City
Mirano (VE)
Country
Italy
Facility Name
Ospedale San Eugenio
City
Rome
Country
Italy
Facility Name
Az. Provinciale per I Serv. Sanit.
City
Trento
Country
Italy
Facility Name
ULSS no. 10
City
Treviso (VE)
Country
Italy
Facility Name
Heart hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation

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