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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01892774
First received: July 1, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention
Chronic Atrial Fibrillation
Procedure: Radiofrequency catheter ablation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients With Chronic Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Improvement in exercise capacity and/or endothelial health [ Time Frame: 5-6 months following catheter ablation ] [ Designated as safety issue: No ]
    Improvement in exercise tolerance and endothelial health as measured by Vmax Encore and Vendys 5000 BC equipment


Secondary Outcome Measures:
  • Improvement in quality of life (QoL) [ Time Frame: 1 year following catheter ablation ] [ Designated as safety issue: No ]
    Improvement in QoL as measured by SF-36 scale

  • Freedom from arrhythmia recurrence [ Time Frame: 1 year post-ablation ] [ Designated as safety issue: No ]
    Arrhythmia free survival as assessed by cardiology evaluations


Other Outcome Measures:
  • Increase in arrhythmia perception [ Time Frame: 1 year post-ablation ] [ Designated as safety issue: No ]
    Change in arrhythmia perception in patients having recurrence


Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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 Pulmonary Vein Antrum Isolation (PVAI) plus ablation of non-pulmonary vein (non-PV) triggers and complex fractionated electrograms (CAFÉ)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892774

Contacts
Contact: Andrea Natale, MD 512-544-8186 dr.natale@gmail.com
Contact: Mitra Mohanty, MD 512-544-8198 mitra.mohanty@stdavids.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Institute, St. david's Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Mitra Mohanty, MD    512-544-8198    mitra.mohanty@stdavids.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
University of Texas at Austin
Investigators
Principal Investigator: Andrea Natale, MD TCAI
  More Information

No publications provided

Responsible Party: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01892774     History of Changes
Other Study ID Numbers: TCAI_Exercise
Study First Received: July 1, 2013
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014