Radiofrequency Ablation of Drivers of Atrial Fibrillation (RADAR-AF)

September 21, 2013 updated by: Felipe Atienza

RADAR-AF: Radiofrequency Ablation of Drivers of Atrial Fibrillation

The purpose of this study is to assess the value of ablation of high frequency sources following circumferential pulmonary veins isolation in patients with paroxysmal and persistent atrial fibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, accounts for one-third of arrhythmia hospitalizations and is associated with an increased risk of stroke, heart failure, and all-cause mortality. Moreover, there is an increasing AF prevalence due to aging of the population, a rising prevalence of chronic heart disease, and increased survival. Unfortunately, medications aimed at suppressing AF and maintaining sinus rhythm or at controlling ventricular rate are only marginally effective and may cause serious adverse effects. The limitations of pharmacologic treatment patterns have fuelled the development of new interventional strategies. Current techniques of AF ablation can achieve a 60-80% improvement in highly selected patients with medically refractory AF. However, the procedure is not without risk, is long-lasting and recurrence rates are still high. Moreover, the results in persistent AF patients are far from optimal, require the creation of extensive atrial lesions and repeated procedures. The main reason that explains the current situation is the incomplete understanding of mechanisms underlying AF maintenance despite many years of research and speculation. The incremental value of ablation of high frequency sources following circumferential PV isolation has not been assessed. There is no prospective data available as to the safety and benefit of such a combined approach in patients with paroxysmal and persistent AF. Such information would be very important in helping guide the future direction of ablative therapy for AF as well as helping to answer important questions about the role of high frequency sites in persistent AF treatment.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

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

  • Spain
      • A Coruña, Spain, 15006
        • Hospital Juan Canalejo
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Bilbao, Spain, 48013
        • Hospital de Basurto
      • Bilbao, Spain, 48014
        • Clínica San Sebastian
      • Granada, Spain, 18014
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28050
        • Grupo Hospital de Madrid
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients age 18 or older.
  • Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication.
  • In patients with paroxysmal AF, at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
  • Patients with persistent AF defined as a sustained episode that had been present for more than seven days without intervening spontaneous episodes of sinus rhythm and that recurred within seven days after cardioversion.
  • Patients with persistent AF must be on continuous anticoagulation with warfarin (INR 2-3) for> 4 weeks prior to ablation. In patients with paroxysmal AF no continuous anticoagulation therapy with warfarin for > 4 weeks prior to ablation will be needed provided a transesophageal echocardiogram performed prior to ablation exclude the presence of thrombi or other abnormalities that discourage performing the procedure.
  • Patients must be able and willing to provide written informed consent to participate in the clinical trial.

Exclusion Criteria:

  • Patients with AF secondary to reversible causes.
  • Patients with inadequate anticoagulation levels as defined in the inclusion criteria.
  • Patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
  • Patients with contraindications to systemic anticoagulation with heparin or coumadin.
  • Patients who have previously undergone atrial fibrillation ablation, either by surgery or by percutaneous catheter.
  • Patients with left atrial size > 55 mm.
  • Patients who are or may potentially be pregnant.
  • Patients with hyperthyroidism or hypothyroidism.
  • Current enrollment in another investigational drug or device study.
  • Pacemaker or Implantable Cardioverter Defibrillator.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1

In patients with paroxysmal atrial fibrillation: Empirical pulmonary vein antrum circumferential isolation.

In patients with persistent atrial fibrillation: Empirical circumferential PV antrum isolation w/out roof line.
Procedure: Radiofrequency catheter ablation

  • In case of Paroxysmal AF, patients will be randomized into one of 2 in the study:

    1. Empirical pulmonary vein antrum circumferential isolation, or
    2. High frequency sites ablation in the LA

  • In case of Persistent AF, patients will be randomized into one of 2 in the study:

    1. Empirical circumferential PV antrum isolation w/out roof line, or
    2. A combined approach involving PV antrum isolation w/out roof line and high frequency sites ablation.
Active Comparator: 2

In patients with paroxysmal atrial fibrillation: High frequency sites ablation in the LA.

In patients with persistent atrial fibrillation: A combined approach involving pulmonary vein antrum isolation w/out roof line and high frequency sites ablation
Procedure: Radiofrequency catheter ablation

  • In case of Paroxysmal AF, patients will be randomized into one of 2 in the study:

    1. Empirical pulmonary vein antrum circumferential isolation, or
    2. High frequency sites ablation in the LA

  • In case of Persistent AF, patients will be randomized into one of 2 in the study:

    1. Empirical circumferential PV antrum isolation w/out roof line, or
    2. A combined approach involving PV antrum isolation w/out roof line and high frequency sites ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from atrial fibrillation at 6 months post-first ablation procedure off antiarrhythmic medications.
Time Frame: 6 month post first-ablation procedure
Freedom from atrial fibrillation at 6 months post-first ablation procedure off antiarrhythmic medications in patients with either paroxysmal or persistent AF (primary analysis population)
6 month post first-ablation procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.
Time Frame: 3, 6 and 12 month post-first ablation procedure
3, 6 and 12 month post-first ablation procedure
Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure
Time Frame: 3, 6 and 12 month post-first ablation
3, 6 and 12 month post-first ablation
Need of redo procedures after 6 months
Time Frame: after 6 month of ablation procedure
after 6 month of ablation procedure
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death
Time Frame: During the procedure and follow-up
During the procedure and follow-up
Procedure duration
Time Frame: During the procedure
During the procedure
Fluoroscopy time
Time Frame: During the procedure
During the procedure
Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure
Time Frame: Baseline, 3, 6 and 12 month
Baseline, 3, 6 and 12 month

Collaborators and Investigators

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

Sponsor

Felipe Atienza

Collaborators

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Investigators

  • Study Director: Felipe Atienza, MD, Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 6, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

September 24, 2013

Last Update Submitted That Met QC Criteria

September 21, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNIC-13

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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