CompletedNot Applicable

Impact of Catheter Ablation of Frequent Premature Ventricular Complexes in Treating Subtle Left Cardiomyopathy

Egypt40 participantsStarted 2023-06-01

Plain-language summary

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: * Is radiofrequency catheter ablation an effective method in the treatment of early subtle myocardial dysfunction in patients with normal left ventricle ejection fraction (LVEF) and internal dimensions guided by 2D STE of GLS before progression into overt LV systolic dysfunction? * Is there a correlation between radiofrequency catheter ablation of asymptomatic frequent idiopathic PVCs and improvement of patient functional capacity as an indicator for subconscious adaptation? * Is there a correlation between PVC burden and the degree of impairment of GLS? 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.

Who can participate

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Asymptomatic patients with frequent idiopathic PVCs, defined as PVCs burden of ≥ 20% of total beats in Holter ECG monitoring in the structurally normal heart as being assessed by conventional 2D echocardiography and normal 12 lead surface ECG. * Impaired LV GLS by 2D speckle tracking (GLS \> -16 %). * Patients willing and capable of providing informed consent Exclusion Criteria: * Multiple co-morbidities that may be potential factors affecting functional capacity including anemia, Chronic obstructive pulmonary disease (COPD), interstitial pulmonary fibrosis, bronchial asthma, Cerebrovascular stroke (CVS), skeletomuscular abnormalities or chronic kidney disease (CKD). * Symptoms including but not limited to fatigue, palpitations, dyspnea, chest pain, dizziness, syncope, presyncope, or functional limitation that was defined as less than the lower limit of predicted 6-minute walk distance (6 MWD). * Any electrolyte abnormalities, abnormal arterial blood gases, and/or abnormal thyroid profile. * Ischemic heart disease (ISHD), in our study ISHD was defined as patients with a previous history of Myocardial infarction, acute coronary syndrome, previous revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG), or objective evidence of myocardial ischemia including noninvasive functional assessment or coronary angiography showing significant stenosis \> 50%. * Symptomatic or asymptomatic structural heart disease in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

global longitudinal strain

Timeframe: minimum of 3 months after (intervention) radio frequency ablation

Trial details

NCT IDNCT06864429

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-23

View on ClinicalTrials.gov More Premature Ventricular Complexes trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.