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

March 11, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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