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

January 8, 2024 updated by: Virginia Commonwealth University

EXCLAMATORY: EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation TO Reduce Atrial Fibrillation Burden and Correlation With Exercise CapacitY Longitudinal Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden will result in favorable LA reverse remodeling - which will result in improved LA reservoir function reserve during exercise, thereby augmenting LV stroke volume reserve during exercise.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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
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 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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Cory Trankle, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20027087
  • K23HL166956 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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