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

This study has been completed.
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah
ClinicalTrials.gov Identifier:
NCT01187914
First received: August 3, 2010
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Atrial Fibrillation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Left Atrial (LA) Remodeling Pre-ablation [ Time Frame: Once pre-ablation ] [ Designated as safety issue: No ]
    Utah staging for fibrosis (I - <=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - >=35.01%)


Enrollment: 40
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Open Irrigation
Those individuals who had an ablation using open irrigation cooled-tip RF ablation.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187914

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

Publications:

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
Study First Received: August 3, 2010
Results First Received: September 23, 2011
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Paroxysmal Atrial Fibrillation
Radio-frequency Ablation
Ablation
Open irrigation cooled-tip

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

ClinicalTrials.gov processed this record on May 16, 2013