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Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients With Chronic Atrial Fibrillation (Exercise)

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ClinicalTrials.gov Identifier: NCT01892774
Recruitment Status : Active, not recruiting
First Posted : July 4, 2013
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study would assess the impact of radio-frequency catheter ablation on exercise capacity and quality of life in long-standing persistent atrial fibrillation (LSP-AF) patients

Condition or disease Intervention/treatment
Chronic Atrial Fibrillation Procedure: Radiofrequency catheter ablation

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Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients With Chronic Atrial Fibrillation
Study Start Date : January 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: Radiofrequency catheter ablation
    Extended PVAI plus ablation of non-pulmonary vein (non-PV) triggers and complex fractionated electrograms (CAFÉ)
    Other Name: Extended PVAI plus ablation of non-PV triggers and CAFE

Outcome Measures

Primary Outcome Measures :
  1. Improvement in exercise capacity and/or endothelial health [ Time Frame: 5-6 months following catheter ablation ]
    Improvement in exercise tolerance and endothelial health as measured by Vmax Encore and Vendys 5000 BC equipment


Secondary Outcome Measures :
  1. Improvement in quality of life (QoL) [ Time Frame: 1 year following catheter ablation ]
    Improvement in QoL as measured by SF-36 scale

  2. Freedom from arrhythmia recurrence [ Time Frame: 1 year post-ablation ]
    Arrhythmia free survival as assessed by cardiology evaluations


Other Outcome Measures:
  1. Increase in arrhythmia perception [ Time Frame: 1 year post-ablation ]
    Change in arrhythmia perception in patients having recurrence


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic asymptomatic long-standing persistent AF
Criteria

Inclusion Criteria:

  • Asymptomatic LSP-AF patients undergoing first catheter ablation
  • > 18-80 years
  • Ability to give consent

Exclusion Criteria:

  • Low LVEF
  • Inability to comply with follow-up testing
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): NCT01892774


Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
University of Texas at Austin
Investigators
Principal Investigator: Andrea Natale, MD TCAI
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01892774     History of Changes
Other Study ID Numbers: TCAI_Exercise
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
LSPAF
asymptomatic
exercise tolerance

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