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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients under going catheter ablation Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden
  • 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)

Recruiting Locations

Virginia Commonwealth University
Richmond, Virginia 23298
Contact:
Pamela Grizzard
804-628-6234
pamela.grizzard@vcuhealth.org

More Details

Status
Recruiting
Sponsor
Virginia Commonwealth University

Study Contact

Pamela Grizzard
804-628-6234
pamela.grizzard@vcuhealth.org

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.