- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00674401
Radiofrequency Ablation of Drivers of Atrial Fibrillation (RADAR-AF)
RADAR-AF: Radiofrequency Ablation of Drivers of Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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A Coruña, Spain, 15006
- Hospital Juan Canalejo
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Barcelona, Spain, 08035
- Hospital Vall D'Hebron
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Bilbao, Spain, 48013
- Hospital de Basurto
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Bilbao, Spain, 48014
- Clínica San Sebastian
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Granada, Spain, 18014
- Hospital Virgen de las Nieves
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Madrid, Spain, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28041
- Hospital 12 de Octubre
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Madrid, Spain, 28050
- Grupo Hospital de Madrid
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Toledo, Spain, 45004
- Hospital Virgen De La Salud
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
|
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 |
|
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
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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
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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
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3, 6 and 12 month post-first ablation
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Need of redo procedures after 6 months
Time Frame: after 6 month of ablation procedure
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after 6 month of ablation procedure
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Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death
Time Frame: During the procedure and follow-up
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During the procedure and follow-up
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Procedure duration
Time Frame: During the procedure
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During the procedure
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Fluoroscopy time
Time Frame: During the procedure
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During the procedure
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Felipe Atienza, MD, Hospital General Universitario Gregorio Marañon
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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