Pulmonary Vein Isolation in Athletes
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|ClinicalTrials.gov Identifier: NCT03226847|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : August 10, 2020
Pulmonary vein isolation (PVI) has become a common and effective treatment for paroxysmal and persistent atrial fibrillation (AF), particularly in patients with drug-refractory disease. Intense endurance exercise is a known risk factor for atrial fibrillation. In general, these athletes poorly tolerate most common antiarrhythmic drugs used for atrial fibrillation control and often PVI is recommended for durable management. While the efficacy of PVI in athletes is similar to the general AF population, some athletes with lone atrial fibrillation report a reduction in subjective exertional capacity following PVI, despite maintenance of sinus rhythm and absence of pulmonary vein stenosis on imaging. The investigators hypothesize that PVI may alter pulmonary vein function and affect peak exercise performance.
The investigators propose a small, prospective study of endurance athletes undergoing antral PVI for treatment of lone atrial fibrillation. Peak metabolic performance and pulmonary vein function will be assessed pre- and post-PVI by metabolic stress testing and cardiac MRI, respectively.
|Condition or disease||Intervention/treatment||Phase|
|Athletes Atrial Fibrillation Catheter Ablation||Procedure: Pulmonary Vein Isolation||Not Applicable|
Endurance athletes with paroxysmal or persistent atrial fibrillation undergoing primary pulmonary vein isolation will be prospectively enrolled prior to PVI.
Patients will undergo metabolic exercise stress testing as well as resting CMR 1-4 weeks prior to PVI. Metabolic stress testing and CMR will be repeated at 6 month follow-up. Quality of life questionnaires will also be collected at pre- and post-PVI visits. Metabolic treadmill stress testing will follow standard protocol and measure hemodynamics with escalating metabolic output and characterize peak exercise capacity (METs) and oxygen consumption (VO2 max).
CMR evaluation will include standard anatomic imaging of pulmonary vein and left atrial anatomy at rest. Additional cine CMR sequences willbe included for focused evaluation of dynamic pulmonary vein cross-sectional area. 3D navigator whole heart imaging and MRA (single gadolinium dose) will be obtained to measure pulmonary vein flow. CMR sequences to characterize left atrial function, including phasic volumes and emptying fractions (total, passive, active) will also be performed.
Data on heart rate variability will additionally be collected at pre- and post-PVI clinic visits, as well as the morning after PVI (hospital day 1).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pulmonary Vein Isolation in Athletes: Effects on Peak Performance and Pulmonary Vein Function|
|Actual Study Start Date :||July 17, 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Pulmonary Vein Isolation
Procedure: Pulmonary Vein Isolation
Standard antral pulmonary vein isolation using radiofrequency ablation catheters
- Peak Oxygen Consumption (VO2) [ Time Frame: up to 6 months ]Assessed by cardiopulmonary stress testing
- Pulmonary vein function [ Time Frame: 1-4 weeks prior to PVI. Reassessed at 6 months post-PVI. ]Change in pulmonary vein cross sectional area measured by resting cardiac MRI
- Heart Rate Variability [ Time Frame: 1-4 weeks prior to PVI. Reassessed at 1 day and 6 months post-PVI. ]Time and frequency domain analysis of subjects heart rate variability using 5- minute protocol
- Subjective Assessment of Athletic Performance [ Time Frame: 1-4 weeks prior to PVI. Reassessed at 6 months post-PVI. ]Measured by athlete-specific questionnaire
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): NCT03226847
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Bryan Baranowski, MD||The Cleveland Clinic|