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Recruiting NCT06212791

EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

— Observational Paroxysmal Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self- Report Evaluation-Duke Activity Status Index, Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire, Cardiopulmonary exercise test (CPET), Transthoracic echocardiogram.
Who it may be relevant to
Registry conditions: Paroxysmal Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

  • Behavioral Self- Report Evaluation-Duke Activity Status Index
    Complete the Self- Report Evaluation-Duke Activity Status Index
  • Behavioral Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire
    Complete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire
  • Diagnostic test Cardiopulmonary exercise test (CPET)
    Cardiopulmonary exercise test (CPET)
  • Diagnostic test Transthoracic echocardiogram
    Transthoracic echocardiogram at rest and immediately following peak exercise during CPET
  • Diagnostic test Ambulatory cardiac rhythm assessment
    Ambulatory cardiac rhythm assessment
  • Diagnostic test Cardiovascular magnetic resonance (CMR)
    Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)

Primary outcome measures

  • 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.]
Secondary outcome measures (6)
  • 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.]
  • 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 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 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 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 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT06212791 · HM20027087 · K23HL166956

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗