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

January 31, 2025 updated by: Biosense Webster EMEA

Catheter Ablation for Cure of Atrial Fibrillation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
within first 24 months after a 2-month run-in phase
Percentage of Procedural Success
Time Frame: The day of the procedure

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.
The day of the procedure
Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase
Time Frame: day 61 through 790
day 61 through 790
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
at 26 months and at each patients last follow-up visit
Quality of Life
Time Frame: at 14, 26 and 38 months
at 14, 26 and 38 months
Health-economics Parameters (Days of Hospitalization)
Time Frame: at 26 months and at each patients last follow-up visit
at 26 months and at each patients last follow-up visit
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
at each patients last follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosense Webster EMEA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emanuele Bertaglia, MD, ULSS n.13, Mirano (VE), Italy
  • Principal Investigator: Giuseppe Stabile, MD, Casa di Cura San Michele, Maddaloni, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2005

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2005

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CACAF2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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