Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pulmonary Vein Isolation in Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226847
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Bryan Baranowski, The Cleveland Clinic

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 Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : July 17, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Peak Oxygen Consumption (VO2) [ Time Frame: up to 6 months ]
    Assessed by cardiopulmonary stress testing


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Principal Investigator: Bryan Baranowski, MD The Cleveland Clinic
Publications:
Layout table for additonal information
Responsible Party: Bryan Baranowski, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03226847    
Other Study ID Numbers: 17-584
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bryan Baranowski, The Cleveland Clinic:
Atrial Fibrillation, Athletes, Pulmonary Vein Isolation
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes