Pulmonary Vein Isolation in Athletes

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03226847
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 44
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Athletes; Atrial Fibrillation; Catheter Ablation	Procedure: Pulmonary Vein Isolation	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pulmonary Vein Isolation in Athletes: Effects on Peak Performance and Pulmonary Vein Function
• Actual Study Start Date: Jul 17, 2017
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Mar 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulmonary Vein Isolation ablation	Procedure: Pulmonary Vein Isolation; Standard antral pulmonary vein isolation using radiofrequency ablation catheters

Outcome Measures

Primary Outcome Measures

1. Peak Oxygen Consumption (VO2) [up to 6 months]

   Assessed by cardiopulmonary stress testing

Secondary Outcome Measures

1. Pulmonary vein function [1-4 weeks prior to PVI. Reassessed at 6 months post-PVI.]

   Change in pulmonary vein cross sectional area measured by resting cardiac MRI

2. Heart Rate Variability [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

3. Subjective Assessment of Athletic Performance [1-4 weeks prior to PVI. Reassessed at 6 months post-PVI.]

   Measured by athlete-specific questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Bryan Baranowski, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Bryan Baranowski, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03226847
• Other Study ID Numbers: 17-584
• First Posted: Jul 24, 2017
• Last Update Posted: Dec 13, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bryan Baranowski, Principal Investigator, The Cleveland Clinic: Atrial Fibrillation, Athletes, Pulmonary Vein Isolation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Dec 13, 2021