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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL166956 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients under going catheter ablation | Patients undergoing catheter ablation for paroxysmal AF, reduction or elimination of arrhythmia burden |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self- Report Evaluation-Duke Activity Status Index | Behavioral | Complete the Self- Report Evaluation-Duke Activity Status Index |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
Pulmonary arterial hypertension
Prior cardiac surgery
Active pregnancy
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pamela Grizzard | Contact | 804-628-6234 | pamela.grizzard@vcuhealth.org | |
| Melissa Sears | Contact | 804-828-1601 | melissa.sears@vcuhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Cory Trankle | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
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| Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire | Behavioral | Complete the Self- Report Evaluation, Atrial Fibrillation Effect on Quality of Life Questionnaire |
|
| Cardiopulmonary exercise test (CPET) | Diagnostic Test | Cardiopulmonary exercise test (CPET) |
|
| Transthoracic echocardiogram | Diagnostic Test | Transthoracic echocardiogram at rest and immediately following peak exercise during CPET |
|
| Ambulatory cardiac rhythm assessment | Diagnostic 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) |
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
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