EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation

Paroxysmal Atrial Fibrillation Clinical Trial

— EXCLAMATORY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212791
• Other study ID #: HM20027087
• Secondary ID: K23HL166956
• Status: Recruiting
• Start date: December 30, 2024
• Est. completion date: March 2028

Study information

• Verified date: January 2024
• Source: Virginia Commonwealth University
• Contact: Pamela Grizzard
• Phone: 804-628-6234
• Email: pamela.grizzard[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Behavioral:
• Self- Report Evaluation-Duke Activity Status Index
Complete the Self- Report Evaluation-Duke Activity Status Index
• 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)
• Transthoracic echocardiogram
Transthoracic echocardiogram at rest and immediately following peak exercise during CPET
• Ambulatory cardiac rhythm assessment
Ambulatory cardiac rhythm assessment
• Cardiovascular magnetic resonance (CMR)
Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary	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.	Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary	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	Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary	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	Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary	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.	Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary	Correlation between baseline AF burden and LA function, LV Function and pVO2	Correlation between baseline AF burden and LA function (rest and exercise), LV function (rest and exercise), and pVO2	Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary	Correlation between the amount of AF burden reduction and the changes in LA function, LV function (rest and exercise), and pVO2.	Correlation between the amount of AF burden reduction and the changes in LA function (rest and exercise), LV function (rest and exercise), and pVO2.	Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.