Paroxysmal Atrial FibrillationEXCLAMATORYNCT06212791
EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation
An observational study of Paroxysmal Atrial Fibrillation, run by Virginia Commonwealth University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Self- Report Evaluation-Duke Activity Status Index, Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire and Cardiopulmonary exercise test (CPET)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Pamela Grizzard, 804-628-6234, pamela.grizzard@vcuhealth.org
Melissa Sears, 804-828-1601, melissa.sears@vcuhealth.org
About this study
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
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).
Read the 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
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Self- Report Evaluation-Duke Activity Status Index, Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire, Cardiopulmonary exercise test (CPET), Transthoracic echocardiogram, Ambulatory cardiac rhythm assessment
- Keywords
- Catheter ablation, Exercise capacity
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self- Report Evaluation-Duke Activity Status IndexBehavioural
Complete the Self- Report Evaluation-Duke Activity Status Index
Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life QuestionnaireBehavioural
Complete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire
Cardiopulmonary exercise test (CPET)Diagnostic test
Cardiopulmonary exercise test (CPET)
Transthoracic echocardiogramDiagnostic test
Transthoracic echocardiogram at rest and immediately following peak exercise during CPET
Ambulatory cardiac rhythm assessmentDiagnostic test
Ambulatory cardiac rhythm assessment
Cardiovascular magnetic resonance (CMR)Diagnostic test
Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR)
| Study group | Role | What they receive |
|---|---|---|
| Patients under going catheter ablation | Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden Receives: Behavioral: Self- Report Evaluation-Duke Activity Status Index; Behavioral: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire; Diagnostic Test: Cardiopulmonary exercise test (CPET); Diagnostic Test: Transthoracic echocardiogram; Diagnostic Test: Ambulatory cardiac rhythm assessment; Diagnostic Test: Cardiovascular magnetic resonance (CMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Secondary outcomes (6)
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.
Measured: 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
Correlation between changes in LA reservoir volume reserve and changes in LV stroke volume reserve after catheter ablation in patients with paroxysmal AF
Measured: 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) .
Correlation between changes in LA reservoir function reserve at submaximal exercise and changes in pVO2 after catheter ablation
Measured: 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
Correlation between changes in LV stroke volume reserve at submaximal exercise and changes in pVO2 after catheter ablation.
Measured: 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
Correlation between baseline AF burden and LA function (rest and exercise), LV function (rest and exercise), and pVO2
Measured: 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.
Correlation between the amount of AF burden reduction and the changes in LA function (rest and exercise), LV function (rest and exercise), and pVO2.
Measured: Baseline and the follow up testing will be performed 5-6 months (to be more specific: 150-180 days) after catheter ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start26 Dec 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Cory Trankle, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212791
- Sponsor's protocol ID
- HM20027087
- Other IDs
- K23HL166956
- Acronym
- EXCLAMATORY
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06212791
- Acronym / sponsor ID
- EXCLAMATORY / HM20027087
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Catheter ablation, Exercise capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under going catheter ablation | – | Behavioral: Self- Report Evaluation-Duke Activity Status Index, Behavioral: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire, Diagnostic Test: Cardiopulmonary exercise test (CPET), Diagnostic Test: Transthoracic echocardiogram, Diagnostic Test: Ambulatory cardiac rhythm assessment, Diagnostic Test: Cardiovascular magnetic resonance (CMR)Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years
- Diagnosis of paroxysmal AF
- Left ventricular ejection fraction ≥50%
- Scheduled for catheter ablation
- Able to speak, hear, and read English
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self- Report Evaluation-Duke Activity Status IndexComplete the Self- Report Evaluation-Duke Activity Status Index | Behavioural | Patients under going catheter ablation |
| Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life QuestionnaireComplete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire | Behavioural | Patients under going catheter ablation |
| Cardiopulmonary exercise test (CPET)Cardiopulmonary exercise test (CPET) | Diagnostic test | Patients under going catheter ablation |
| Transthoracic echocardiogramTransthoracic echocardiogram at rest and immediately following peak exercise during CPET | Diagnostic test | Patients under going catheter ablation |
| Ambulatory cardiac rhythm assessmentAmbulatory cardiac rhythm assessment | Diagnostic test | Patients under going catheter ablation |
| Cardiovascular magnetic resonance (CMR)Cardiovascular magnetic resonance (CMR) study at rest and during two stages of submaximal exercise (ExeCMR) | Diagnostic test | Patients under going catheter ablation |
Primary outcome
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.
6 secondary outcomes
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.
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 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 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 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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cory Trankle principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Grizzard (804-628-6234, pamela.grizzard@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.