Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Premature Ventricular Contractions

Treatments: Procedure: intracardiac echocardiography (ICE)-guided catheter ablation; Procedure: Pressure-sensing catheter ablation alone

Study type: Interventional

Funder types: Other

Identifiers

NCT06898281

ICE-PMPVC

Details and patient eligibility

About

This randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ICE)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing PVC recurrence among patients with confirmed papillary muscle-originating premature ventricular contractions (PVCs). Participants were randomly allocated to either the ICE-guided intervention group or the conventional ablation control group following definitive diagnosis.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥18 years.
• Diagnosed with premature ventricular contractions (PVCs) originating from the papillary muscles.
• Symptoms refractory to antiarrhythmic drug therapy.
• Patients must be capable and willing to provide written informed consent for study participation.

Exclusion criteria

• History of cardiac surgery or any prior cardiac interventional procedures.
• Ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
• Severe hepatic or renal dysfunction:

AST/ALT >3× upper limit of normal (ULN); Serum creatinine (SCr) >3.5 mg/dl or creatinine clearance (Ccr) <30 ml/min.

• Prior ablation for papillary muscle PVCs.
• Life expectancy <1 year.
• Pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups

intracardiac echocardiography (ICE)-guided catheter ablation

Experimental group

Description:

Intracardiac echocardiography (ICE)-guided catheter ablation.

Treatment:

Procedure: intracardiac echocardiography (ICE)-guided catheter ablation

Pressure-sensing catheter ablation alone

Active Comparator group

Description:

Pressure-sensing catheter ablation alone.

Treatment:

Procedure: Pressure-sensing catheter ablation alone