Clinical trial NCT06212791: EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation
Official title: EXCLAMATORY: EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation TO Reduce Atrial Fibrillation Burden and Correlation With Exercise CapacitY Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Catheter ablation
Exercise capacity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in LA reservoir function reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.
timeFrame: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary outcomes:
measure: Change in LV stroke volume reserve at submaximal exercise after catheter ablation in patients with paroxysmal AF.
timeFrame: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
measure: Correlation between changes in LA reservoir volume reserve and changes in LV stroke vol reserve after catheter ablation in patients with paroxysmal AF
timeFrame: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
measure: Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in mixed venous oxygen tension (pVO2) .
timeFrame: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
measure: Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2
timeFrame: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
measure: Correlation between baseline AF burden and LA function, LV Function and pVO2
timeFrame: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
measure: Correlation between the amount of AF burden reduction and the changes in LA function, LV function (rest and exercise), and pVO2.
timeFrame: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Cory Trankle
role: PRINCIPAL_INVESTIGATOR
References: