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NCT Number: NCT06212791

EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

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).

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Change in LA reservoir function reserve at submaximal exercise 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.

    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

  1. Change in LV stroke volume reserve at submaximal exercise 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.

    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.

  2. Correlation between changes in LA reservoir volume reserve and changes in LV stroke vol 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.

    Correlation between changes in LA reservoir volume reserve and changes in LV stroke volume reserve after catheter ablation in patients with paroxysmal AF

  3. Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in mixed venous oxygen tension (pVO2) .

    Time frame: 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

  4. Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2

    Time frame: 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.

  5. Correlation between baseline AF burden and LA function, LV Function and pVO2

    Time frame: 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

  6. Correlation between the amount of AF burden reduction and the changes in LA function, LV function (rest and exercise), and pVO2.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Sears

CONTACT

[email protected]

804-828-1601

Pamela Grizzard

CONTACT

[email protected]

804-628-6234

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study 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

Acronym: EXCLAMATORY

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 19, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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