NCT00674401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

3.8 years

First QC Date

May 6, 2008

Last Update Submit

September 21, 2013

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • 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

  • 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

  • Need of redo procedures after 6 months

    after 6 month of ablation procedure

  • Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death

    During the procedure and follow-up

  • Procedure duration

    During the procedure

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

Radiofrequency catheter ablationPROCEDURE

* 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.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with AF secondary to reversible causes.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital Juan Canalejo

A Coruña, A Coruña, 15006, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital de Basurto

Bilbao, Bilbao, 48013, Spain

Location

Clínica San Sebastian

Bilbao, Bilbao, 48014, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Grupo Hospital de Madrid

Madrid, Madrid, 28050, Spain

Location

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25500229DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Felipe Atienza, MD

    Hospital General Universitario Gregorio Marañon

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

January 1, 2009

Primary Completion

November 1, 2012

Study Completion

May 1, 2013

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

ES(11)