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Throughout the past decade, there were no straightforward recommendations regarding the management of asymptomatic high-burden Premature ventricular complexes (PVCs) in structurally normal heart extending from the European Society of Cardiology (ESC) guidelines of management of ventricular arrhythmias in 2014, passing by the American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Association (HRA) guidelines 2017, and reaching to the recent ESC guidelines in 2022 that declared overtly that there is a gap of evidence regarding management of asymptomatic high burden PVCs in structurally normal heart.
The goal of this clinical trial is to know if other imaging modalities rather than the conventional Two-dimension (2D) echocardiography can guide the treatment strategy of high-burden idiopathic premature ventricular complexes (PVCs). In our clinical trial, we used 2D speckle tracking of left ventricular (LV) global longitudinal strain (GLS) as an indicator for subtle LV systolic dysfunction in patients with structurally normal heart by conventional echocardiography.
The main questions the trial aims to answer are:
Researchers will compare group A (control group) and group B (ablation group) to see if there is a significant difference between them regarding global longitudinal strain.
Participants will be randomized into two groups each containing 20 patients. Group A (Control group): will be subjected to the standard of care being regular follow-up of symptom status and left ventricular ejection fraction (LVEF) Group B (ablation group): will be scheduled for PVC ablation.
The clinical trial was conducted from June 2023 to August 2024. A total of 218 patients entered the screening phase. Of that participant pool, 116 patients did not fulfill the eligibility criteria since 90 patients were symptomatic, 33 patients had more than one PVC morphology in Holter ECG monitoring, 10 patients had episodes of atrial fibrillation (AF) in Holter ECG monitoring, 2 patients were diagnosed with chronic obstructive pulmonary disease (COPD), 1 patient had chronic kidney disease (CKD).
The other 100 patients continued with the subsequent stage of assessment of LV GLS, as mentioned in the outlined methodology. Of this cohort, 60 patients were excluded from the study because they did not meet the criteria for randomization, as they showed normal LV GLS ≥ -16%.
Accordingly, our study was conducted on 40 patients meeting the inclusion criteria mentioned. Those patients were further randomized into two groups each containing 20 patients.
Group A (Control group): subjected to the standard of care being regular follow-up of symptom status and left ventricular ejection fraction (LVEF) Group B (ablation group): scheduled for PVC ablation.
After a minimum duration of 3 months all participants were applied to follow-up assessment of symptoms status, 6-minute walk test (6MWT), PVC burden by Holter ECG monitoring, LV GLS by speckle tracking Echocardiography (STE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A (control arm) | No Intervention | Group A is the control arm that will be applied to the standard of care treatment which is follow-up of symptoms status and left ventricular ejection fraction as per the recommendation of ESC guidelines of management of ventricular arrhythmias and sudden cardiac death published in 2022. | |
| Group B (ablation arm) | Active Comparator | Group B is the ablation arm that will be scheduled for radiofrequency catheter ablation of PVCs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency catheter ablation | Procedure | Radiofrequency (RF) catheter ablation is a minimally invasive procedure that targets and eliminates certain types of cardiac arrhythmias. RF became effective as the first-line treatment for ventricular arrhythmias in some circumstances. |
| Measure | Description | Time Frame |
|---|---|---|
| global longitudinal strain | change of left ventricular global longitudinal strain was an indicator of the effectiveness of radiofrequency ablation in the treatment of subtle LV systolic dysfunction and prevention of further progression into overt cardiomyopathy. | minimum of 3 months after (intervention) radio frequency ablation |
| Measure | Description | Time Frame |
|---|---|---|
| functional capacity | The trial aims to assess the correlation between radiofrequency catheter ablation of asymptomatic frequent idiopathic PVCs and change of patient functional capacity that is evaluated by a 6-minute walk test as an indicator for subconscious adaptation | minimum of 3 months after (intervention) radio frequency ablation |
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Inclusion Criteria:
Exclusion Criteria:
male and female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university hospital | Cairo | Abbasya | +20 | Egypt |
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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group B ( ablation arm), will be applied for radiofrequency catheter ablation of PVCs as a treatment strategy.
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|
| PVC burden |
The trial aims to assess the correlation between PVC burden and the degree of impairment of GLS |
| minimum of 3 months after (intervention) radio frequency ablation |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |