Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients With Chronic Atrial Fibrillation
Exercise
1 other identifier
observational
150
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 10, 2019
April 1, 2019
8.9 years
July 1, 2013
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in exercise capacity and/or endothelial health
Improvement in exercise tolerance and endothelial health as measured by Vmax Encore and Vendys 5000 BC equipment
5-6 months following catheter ablation
Secondary Outcomes (2)
Improvement in quality of life (QoL)
1 year following catheter ablation
Freedom from arrhythmia recurrence
1 year post-ablation
Other Outcomes (1)
Increase in arrhythmia perception
1 year post-ablation
Interventions
Extended PVAI plus ablation of non-pulmonary vein (non-PV) triggers and complex fractionated electrograms (CAFÉ)
Eligibility Criteria
Chronic asymptomatic long-standing persistent AF
You may qualify if:
- Asymptomatic LSP-AF patients undergoing first catheter ablation
- \> 18-80 years
- Ability to give consent
You may not qualify if:
- Low LVEF
- Inability to comply with follow-up testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Cardiac Arrhythmia Institute, St. david's Medical Center
Austin, Texas, 78705, United States
Related Publications (1)
Mohanty S, Santangeli P, Mohanty P, Di Biase L, Holcomb S, Trivedi C, Bai R, Burkhardt D, Hongo R, Hao S, Beheiry S, Santoro F, Forleo G, Gallinghouse JG, Horton R, Sanchez JE, Bailey S, Hranitzky PM, Zagrodzky J, Natale A. Catheter ablation of asymptomatic longstanding persistent atrial fibrillation: impact on quality of life, exercise performance, arrhythmia perception, and arrhythmia-free survival. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1057-64. doi: 10.1111/jce.12467. Epub 2014 Jul 7.
PMID: 24903064DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natale, MD
TCAI
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2013
First Posted
July 4, 2013
Study Start
January 1, 2010
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
April 10, 2019
Record last verified: 2019-04