EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVirginia Commonwealth University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Self- Report Evaluation-Duke Activity Status Index

    Behavioral

    Complete the Self- Report Evaluation-Duke Activity Status Index

  • Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire

    Behavioral

    Complete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire

  • Cardiopulmonary exercise test (CPET)

    Diagnostic test

    Cardiopulmonary exercise test (CPET)

  • Transthoracic echocardiogram

    Diagnostic test

    Transthoracic echocardiogram at rest and immediately following peak exercise during CPET

  • Ambulatory cardiac rhythm assessment

    Diagnostic test

    Ambulatory cardiac rhythm assessment

  • Cardiovascular magnetic resonance (CMR)

    Diagnostic test

    Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients under going catheter ablation6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

Secondary outcomes

1

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.

Time frame
Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
2

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

Time frame
Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
3

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

Time frame
Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
4

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.

Time frame
Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator