An interventional study of Radiofrequency catheter ablation in Premature Ventricular Complexes and Ventricular Arrhythmias, sponsored by Ain Shams University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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).
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's enrollment of 40 is below the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 is the ablation arm that will be scheduled for radiofrequency catheter ablation of PVCs.
Procedure: Radiofrequency catheter ablation
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.
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.
Time frame: minimum of 3 months after (intervention) radio frequency ablation
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
Time frame: minimum of 3 months after (intervention) radio frequency ablation
PVC burden
The trial aims to assess the correlation between PVC burden and the degree of impairment of GLS
Time frame: minimum of 3 months after (intervention) radio frequency ablation
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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