Radiofrequency Ablation of Drivers of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— RADAR-AF  

Official title:

RADAR-AF: Radiofrequency Ablation of Drivers of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674401
• Other study ID #: CNIC-13
• Status: Completed
• Phase: N/A
• First received: May 6, 2008
• Last updated: September 21, 2013
• Start date: January 2009
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Radiofrequency catheter ablation
In case of Paroxysmal AF, patients will be randomized into one of 2 in the study: Empirical pulmonary vein antrum circumferential isolation, or High frequency sites ablation in the LA In case of Persistent AF, patients will be randomized into one of 2 in the study: Empirical circumferential PV antrum isolation w/out roof line, or A combined approach involving PV antrum isolation w/out roof line and high frequency sites ablation.

Locations

Country	Name	City	State
Spain	Hospital Juan Canalejo	A Coruña
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Clínica San Sebastian	Bilbao
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Virgen de las Nieves	Granada
Spain	Grupo Hospital de Madrid	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Virgen de la Salud	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
Felipe Atienza	Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation at 6 months post-first ablation procedure off antiarrhythmic medications.	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	No
Secondary	Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.		3, 6 and 12 month post-first ablation procedure	No
Secondary	Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure		3, 6 and 12 month post-first ablation	No
Secondary	Need of redo procedures after 6 months		after 6 month of ablation procedure	No
Secondary	Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death		During the procedure and follow-up	Yes
Secondary	Procedure duration		During the procedure	No
Secondary	Fluoroscopy time		During the procedure	No
Secondary	Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure		Baseline, 3, 6 and 12 month	No