About this trial
Longitudinal, observational cohort study to evaluate changes in left atrial (LA) reservoir function during exercise and overall exertional capacity in patients following catheter ablation for paroxysmal atrial fibrillation (AF).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Diagnosis of paroxysmal AF
Left ventricular ejection fraction ≥50%
Scheduled for catheter ablation
Disqualifiers
Persistent or permanent AF
Prior ablation (catheter based or surgical) for AF
Significant sinus node dysfunction
Implanted pacemaker or defibrillator
Trial population
In patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden will result in favorable LA reverse remodeling - which will result in improved LA reservoir function reserve during exercise, thereby augmenting LV stroke volume reserve during exercise.
Trial design
Cohort
Prospective
Treatments tested in this trial
Self- Report Evaluation-Duke Activity Status Index
BehavioralComplete the Self- Report Evaluation-Duke Activity Status Index
Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire
BehavioralComplete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire
Cardiopulmonary exercise test (CPET)
Diagnostic testCardiopulmonary exercise test (CPET)
Transthoracic echocardiogram
Diagnostic testTransthoracic echocardiogram at rest and immediately following peak exercise during CPET
Ambulatory cardiac rhythm assessment
Diagnostic testAmbulatory cardiac rhythm assessment
Cardiovascular magnetic resonance (CMR)
Diagnostic testCardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)
Treatment groups
Trial outcomes
Primary outcomes
Change in LA reservoir function reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.
Change in LA reservoir volume reserve from baseline to follow up, change in left ventricular (LV) stroke volume reserve from baseline to follow up, correlation between changes in LA reservoir volume reserve and changes in LV stroke volume reserve. Therefore the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary outcomes
Change in LV stroke volume reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.
Change in LA reservoir volume reserve from baseline to follow up, change in LV stroke volume reserve from baseline to follow up, correlation between changes in LA reservoir volume reserve and changes in LV stroke volume reserve.
Correlation between changes in LA reservoir volume reserve and changes in LV stroke vol reserve after catheter ablation in patients with paroxysmal AF
Correlation between changes in LA reservoir volume reserve and changes in LV stroke volume reserve after catheter ablation in patients with paroxysmal AF
Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in mixed venous oxygen tension (pVO2) .
Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in pVO2 after catheter ablation
Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2
Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2 after catheter ablation.
Sponsors and contacts
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Virginia Commonwealth University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator