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

NCT06864429 | Completed DMC

• 1 other identifier: FMASU MD102/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Ventricular Complexes; Ventricular Arrhythmias

Keywords

catheter ablation; radiofrequency ablation; Premature ventricular complexes; global longitudinal strain; PVCs induced cardiomyopathy; Idiopathic PVCs; Speckle tracking

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• functional capacity

  minimum of 3 months after (intervention) radio frequency ablation

• PVC burden

  minimum of 3 months after (intervention) radio frequency ablation

Study Arms (2)

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.

Procedure: Radiofrequency catheter ablation

Interventions

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.

Group B (ablation arm)

Eligibility Criteria

• Gender Eligibility Details: male and female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 including any congenital heart diseases, significant valvular lesion defined as primary or secondary valvular lesion causing abnormal loading condition, or more than grade I diastolic dysfunction.
• Any symptomatic or asymptomatic phenotype of cardiomyopathies.
• Polymorphic PVCs.
• Atrial fibrillation.
• Positive family history of sudden cardiac death.
• Heart failure including heart failure with preserved ejection fraction (HFpEF), heart failure with mildly reduced ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospital

Cairo, Abbasya, +20, Egypt

Location

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: group B ( ablation arm), will be applied for radiofrequency catheter ablation of PVCs as a treatment strategy.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 7, 2025
• Study Start: June 1, 2023
• Primary Completion: May 23, 2024
• Study Completion: August 28, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-01

Locations

EG (1)