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

This study has been completed.
Sponsor:
Collaborator:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Information provided by (Responsible Party):
Felipe Atienza, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT00674401
First received: May 6, 2008
Last updated: September 21, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Radiofrequency catheter ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: RADAR-AF: Radiofrequency Ablation of Drivers of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:
  • Freedom from atrial fibrillation at 6 months post-first ablation procedure off antiarrhythmic medications. [ Time Frame: 6 month post first-ablation procedure ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Need of redo procedures after 6 months [ Time Frame: after 6 month of ablation procedure ] [ Designated as safety issue: No ]
  • Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death [ Time Frame: During the procedure and follow-up ] [ Designated as safety issue: Yes ]
  • Procedure duration [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure [ Time Frame: Baseline, 3, 6 and 12 month ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: January 2009
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674401

Locations
Spain
Hospital Juan Canalejo
A Coruña, Spain, 15006
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital de Basurto
Bilbao, Spain, 48013
Clínica San Sebastian
Bilbao, Spain, 48014
Hospital Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain, 28046
Grupo Hospital de Madrid
Madrid, Spain, 28050
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Virgen de la Salud
Toledo, Spain, 45004
Sponsors and Collaborators
Felipe Atienza
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Investigators
Study Director: Felipe Atienza, MD Hospital General Universitario Gregorio Marañon
  More Information

No publications provided

Responsible Party: Felipe Atienza, MD, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT00674401     History of Changes
Other Study ID Numbers: CNIC-13
Study First Received: May 6, 2008
Last Updated: September 21, 2013
Health Authority: Spain: Ministry of Health and Consumption

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

ClinicalTrials.gov processed this record on August 21, 2014