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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radiofrequency catheter ablation
Sponsored by
Felipe Atienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Juan Canalejo
  • Hospital Vall d'Hebron
  • Hospital de Basurto
  • Clínica San Sebastian
  • Hospital Virgen de las Nieves
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Ramón y Cajal
  • Hospital 12 de Octubre
  • Hospital Universitario La Paz
  • Grupo Hospital de Madrid
  • Hospital Virgen de la Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2008
Last Updated
September 21, 2013
Sponsor
Felipe Atienza
Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT00674401
Brief Title
Radiofrequency Ablation of Drivers of Atrial Fibrillation
Acronym
RADAR-AF
Official Title
RADAR-AF: Radiofrequency Ablation of Drivers of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Felipe Atienza
Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation at 6 months post-first ablation procedure off antiarrhythmic medications.
Description
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)
Time Frame
6 month post first-ablation procedure
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Need of redo procedures after 6 months
Time Frame
after 6 month of ablation procedure
Title
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death
Time Frame
During the procedure and follow-up
Title
Procedure duration
Time Frame
During the procedure
Title
Fluoroscopy time
Time Frame
During the procedure
Title
Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure
Time Frame
Baseline, 3, 6 and 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Atienza, MD
Organizational Affiliation
Hospital General Universitario Gregorio Marañon
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Juan Canalejo
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Clínica San Sebastian
City
Bilbao
ZIP/Postal Code
48014
Country
Spain
Facility Name
Hospital Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Grupo Hospital de Madrid
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25500229
Citation
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.
Results Reference
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Radiofrequency Ablation of Drivers of Atrial Fibrillation

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