EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation (EXCLAMATORY)

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Diagnostic Test: Ambulatory cardiac rhythm assessment; Diagnostic Test: Cardiovascular magnetic resonance (CMR); Diagnostic Test: Transthoracic echocardiogram; Diagnostic Test: Cardiopulmonary exercise test (CPET); Behavioral: Self- Report Evaluation-Duke Activity Status Index; Behavioral: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06212791

K23HL166956 (U.S. NIH Grant/Contract)

HM20027087

Details and patient eligibility

About

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).

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Patients under going catheter ablation

Description:

Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden

Treatment:

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

Behavioral: Self- Report Evaluation-Duke Activity Status Index

Diagnostic Test: Cardiopulmonary exercise test (CPET)

Diagnostic Test: Transthoracic echocardiogram

Diagnostic Test: Cardiovascular magnetic resonance (CMR)

Diagnostic Test: Ambulatory cardiac rhythm assessment