Paroxysmal Atrial Fibrillation
Conditions
Keywords
Catheter ablation, Exercise capacity
Brief summary
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).
Detailed description
EXCLAMATORY is a longitudinal observational cohort clinical research study to evaluate the effects of catheter ablation for paroxysmal atrial fibrillation on left atrial and left ventricular performance during exercise, as well as effects on overall exercise capacity
Interventions
BEHAVIORALSelf- Report Evaluation-Duke Activity Status Index
Complete the Self- Report Evaluation-Duke Activity Status Index
BEHAVIORALSelf- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire
Complete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire
DIAGNOSTIC_TESTCardiopulmonary exercise test (CPET)
Cardiopulmonary exercise test (CPET)
DIAGNOSTIC_TESTTransthoracic echocardiogram
Transthoracic echocardiogram at rest and immediately following peak exercise during CPET
DIAGNOSTIC_TESTAmbulatory cardiac rhythm assessment
Ambulatory cardiac rhythm assessment
DIAGNOSTIC_TESTCardiovascular magnetic resonance (CMR)
Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)
Sponsors
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Diagnosis of paroxysmal AF * Left ventricular ejection fraction ≥50% * Scheduled for catheter ablation * Able to speak, hear, and read English * Willing and able to provide informed consent
Exclusion criteria
* Persistent or permanent AF * Prior ablation (catheter based or surgical) for AF * Significant sinus node dysfunction * Implanted pacemaker or defibrillator * Contraindication to or inability to complete cardiovascular magnetic resonance study * Contraindication to or inability to complete exercise testing * Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73m2 * Severe left ventricular hypertrophy * Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to: * Hypertrophic cardiomyopathy * Cardiac amyloidosis * Constrictive pericarditis * Pulmonary arterial hypertension * Prior cardiac surgery * Active pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LA reservoir function reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF. | Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in LV stroke volume reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF. | Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation. | 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 | Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation. | 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) . | Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation. | 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 | Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation. | Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2 after catheter ablation. |
| Correlation between baseline AF burden and LA function, LV Function and pVO2 | Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation. | Correlation between baseline AF burden and LA function (rest and exercise), LV function (rest and exercise), and pVO2 |
| Correlation between the amount of AF burden reduction and the changes in LA function, LV function (rest and exercise), and pVO2. | Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation. | Correlation between the amount of AF burden reduction and the changes in LA function (rest and exercise), LV function (rest and exercise), and pVO2. |
Countries
United States
Contacts
CONTACTPamela Grizzard
CONTACTMelissa Sears
PRINCIPAL_INVESTIGATORCory Trankle
Virginia Commonwealth University
Outcome results
None listed