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Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium (RADAR)

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ClinicalTrials.gov Identifier: NCT01187914
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : January 10, 2012
Last Update Posted : February 13, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the impact of pre-ablation fibrosis on scar formation in the left atrium of the heart. This will be assessed by delayed enhancement magnetic resonance imaging and will be looked at in patients who have undergone successful open irrigated cooled-tipped radio-frequency ablation of paroxysmal atrial fibrillation. Follow-up after ablation will be for 12 months.

Condition or disease
Atrial Fibrillation

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: RADAR: Effect of Structural Remodeling on Scar Formation as Assessed by DE-MRI of the Left Atrium Following Open-Irrigation Cooled-Tip Radiofrequency Catheter Ablation of Paroxysmal Atrial Fibrillation
Study Start Date : August 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Open Irrigation
Those individuals who had an ablation using open irrigation cooled-tip RF ablation.

Outcome Measures

Primary Outcome Measures :
  1. Left Atrial (LA) Remodeling Pre-ablation [ Time Frame: Once pre-ablation ]
    Utah staging for fibrosis (I - <=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - >=35.01%)

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Forty patients ages 18-89 years, who have had an open irrigation cooled-tipped RF ablation procedure for PAF. Patients must participate in 3-, 6-, and 12-months follow-up post ablation. PAF is defined by >2 documented episodes of AF that terminate spontaneously within 7 days. AF has to be documented by means of electrocardiography, holter monitor, loop recorder, or echocardiography.

Inclusion Criteria:

  • > 17 years-old and < 90 years-old
  • Long-term care for PAF
  • Participated in regular clinical follow-ups

Exclusion Criteria:

  • Patients who did not receive long-term follow-up care defined as at least 12-months post ablation.
  • Women who were pregnant during the time period to be covered by this study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187914

Sponsors and Collaborators
University of Utah
Biosense Webster, Inc.
Principal Investigator: Nassir F Marrouche, MD University of Utah
More Information


Responsible Party: Nassir F. Marrouche, MD, Associate Professor of cardiology, University of Utah
ClinicalTrials.gov Identifier: NCT01187914     History of Changes
Other Study ID Numbers: IRB_00042859
First Posted: August 24, 2010    Key Record Dates
Results First Posted: January 10, 2012
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by Nassir F. Marrouche, MD, University of Utah:
Paroxysmal Atrial Fibrillation
Radio-frequency Ablation
Open irrigation cooled-tip

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes