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Completed

NCT Number: NCT03226847

Pulmonary Vein Isolation in Athletes

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.

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Key information

Conditions

Athletes Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary vein isolation

Procedure

Standard antral pulmonary vein isolation using radiofrequency ablation catheters

Primary outcomes

  1. Peak Oxygen Consumption (VO2)

    Time frame: up to 6 months

    Assessed by cardiopulmonary stress testing

Secondary outcomes

  1. 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

  2. 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

  3. Subjective Assessment of Athletic Performance

    Time frame: 1-4 weeks prior to PVI. Reassessed at 6 months post-PVI.

    Measured by athlete-specific questionnaire

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Pulmonary Vein Isolation in Athletes: Effects on Peak Performance and Pulmonary Vein Function

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jul 24, 2017
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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