Pulmonary Vein Isolation in Athletes

NCT03226847 | Completed

• 1 other identifier: 17-584
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Athletes; Atrial Fibrillation; Catheter Ablation

Keywords

Atrial Fibrillation, Athletes, Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen Consumption (VO2)

  Assessed by cardiopulmonary stress testing

  up to 6 months

Secondary Outcomes (3)

• Pulmonary vein function

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

• Heart Rate Variability

  1-4 weeks prior to PVI. Reassessed at 1 day and 6 months post-PVI.

• Subjective Assessment of Athletic Performance

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

Study Arms (1)

Pulmonary Vein Isolation

EXPERIMENTAL

ablation

Procedure: Pulmonary Vein Isolation

Interventions

Pulmonary Vein Isolation PROCEDURE

Standard antral pulmonary vein isolation using radiofrequency ablation catheters

Pulmonary Vein Isolation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal or Persistent AF
• Endurance or highly trained athletes (\>3H training/week for \>10 yrs)
• NSR at time of stress testing

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 19923171 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryan Baranowski, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: July 17, 2017
• Primary Completion: June 30, 2020
• Study Completion: March 16, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)