Radiofrequency Ablation of Drivers of Atrial Fibrillation

NCT ID: NCT00674401

Last Updated: 2013-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-05-31

Brief Summary

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency catheter ablation

Intervention Type: PROCEDURE

• 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.

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

Group Type: ACTIVE_COMPARATOR

Radiofrequency catheter ablation

Intervention Type: PROCEDURE

• 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• 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.

Exclusion Criteria

• Patients with AF secondary to reversible causes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

OTHER

Sponsor Role: collaborator

Felipe Atienza

OTHER

Sponsor Role: lead

Responsible Party

Felipe Atienza

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Felipe Atienza, MD

Role: STUDY_DIRECTOR

Hospital General Universitario Gregorio Marañon

Locations

Hospital Juan Canalejo

A Coruña, A Coruña, Spain

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital de Basurto

Bilbao, Bilbao, Spain

Clínica San Sebastian

Bilbao, Bilbao, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Grupo Hospital de Madrid

Madrid, Madrid, Spain

Hospital Virgen de las Nieves

Granada, , Spain

Hospital Virgen de la Salud

Toledo, , Spain

Countries

Spain

References

Atienza F, Almendral J, Ormaetxe JM, Moya A, Martinez-Alday JD, Hernandez-Madrid A, Castellanos E, Arribas F, Arias MA, Tercedor L, Peinado R, Arcocha MF, Ortiz M, Martinez-Alzamora N, Arenal A, Fernandez-Aviles F, Jalife J; RADAR-AF Investigators. Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial. J Am Coll Cardiol. 2014 Dec 16;64(23):2455-67. doi: 10.1016/j.jacc.2014.09.053.

Reference Type: DERIVED

PMID: 25500229 (View on PubMed)

Other Identifiers

CNIC-13

Identifier Type: -

Identifier Source: org_study_id