Pulmonary Vein Isolation in Athletes
Primary Purpose
Athletes, Atrial Fibrillation, Catheter Ablation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Vein Isolation
Sponsored by
About this trial
This is an interventional treatment trial for Athletes focused on measuring Atrial Fibrillation, Athletes, Pulmonary Vein Isolation
Eligibility Criteria
Inclusion Criteria:
- Paroxysmal or Persistent AF
- Endurance or highly trained athletes (>3H training/week for >10 yrs)
- NSR at time of stress testing
Exclusion Criteria:
- Structural Heart Disease; LVEF <45%
- Moderate or Severe Valvular disease
- eGFR < 30
- Contraindication to MRI
- Less than average functional capacity
- Previous episode of AF of >14 days duration
- Previous pulmonary vein isolation
- Imaging evidence of pulmonary vein stenosis
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary Vein Isolation
Arm Description
ablation
Outcomes
Primary Outcome Measures
Peak Oxygen Consumption (VO2)
Assessed by cardiopulmonary stress testing
Secondary Outcome Measures
Pulmonary vein function
Change in pulmonary vein cross sectional area measured by resting cardiac MRI
Heart Rate Variability
Time and frequency domain analysis of subjects heart rate variability using 5- minute protocol
Subjective Assessment of Athletic Performance
Measured by athlete-specific questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03226847
Brief Title
Pulmonary Vein Isolation in Athletes
Official Title
Pulmonary Vein Isolation in Athletes: Effects on Peak Performance and Pulmonary Vein Function
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletes, Atrial Fibrillation, Catheter Ablation
Keywords
Atrial Fibrillation, Athletes, Pulmonary Vein Isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Vein Isolation
Arm Type
Experimental
Arm Description
ablation
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Vein Isolation
Intervention Description
Standard antral pulmonary vein isolation using radiofrequency ablation catheters
Primary Outcome Measure Information:
Title
Peak Oxygen Consumption (VO2)
Description
Assessed by cardiopulmonary stress testing
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Pulmonary vein function
Description
Change in pulmonary vein cross sectional area measured by resting cardiac MRI
Time Frame
1-4 weeks prior to PVI. Reassessed at 6 months post-PVI.
Title
Heart Rate Variability
Description
Time and frequency domain analysis of subjects heart rate variability using 5- minute protocol
Time Frame
1-4 weeks prior to PVI. Reassessed at 1 day and 6 months post-PVI.
Title
Subjective Assessment of Athletic Performance
Description
Measured by athlete-specific questionnaire
Time Frame
1-4 weeks prior to PVI. Reassessed at 6 months post-PVI.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Paroxysmal or Persistent AF
Endurance or highly trained athletes (>3H training/week for >10 yrs)
NSR at time of stress testing
Exclusion Criteria:
Structural Heart Disease; LVEF <45%
Moderate or Severe Valvular disease
eGFR < 30
Contraindication to MRI
Less than average functional capacity
Previous episode of AF of >14 days duration
Previous pulmonary vein isolation
Imaging evidence of pulmonary vein stenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Baranowski, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19923171
Citation
Calvo N, Mont L, Tamborero D, Berruezo A, Viola G, Guasch E, Nadal M, Andreu D, Vidal B, Sitges M, Brugada J. Efficacy of circumferential pulmonary vein ablation of atrial fibrillation in endurance athletes. Europace. 2010 Jan;12(1):30-6. doi: 10.1093/europace/eup320.
Results Reference
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Pulmonary Vein Isolation in Athletes
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