EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

Recruiting

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Behavioral: Self- Report Evaluation-Duke Activity Status Index; Behavioral: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire; Diagnostic Test: Cardiopulmonary exercise test (CPET); Diagnostic Test: Transthoracic echocardiogram; Diagnostic Test: Ambulatory cardiac rhythm assessment; Diagnostic Test: Cardiovascular magnetic resonance (CMR)

• Registration Number: NCT06212791
• Lead Sponsor: Virginia Commonwealth University

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

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-19
• Study Start: 2024-12-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients under going catheter ablation	Cardiopulmonary exercise test (CPET)	Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
Patients under going catheter ablation	Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire	Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
Patients under going catheter ablation	Self- Report Evaluation-Duke Activity Status Index	Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
Patients under going catheter ablation	Transthoracic echocardiogram	Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
Patients under going catheter ablation	Ambulatory cardiac rhythm assessment	Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
Patients under going catheter ablation	Cardiovascular magnetic resonance (CMR)	Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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 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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States