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

Not Applicable

Active, not recruiting

• Conditions: Premature Ventricular Contractions

• Registration Number: NCT06898281
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-22
• Study First Submitted QC: 2025-03-22
• Study Start: 2025-03-23
• Study First Posted: 2025-03-27
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from VC recurrence	Patients were followed up at 3 months postoperatively to assess recurrence.	Freedom from VC recurrence (defined as a ≥80% reduction in VC burden, calculated as \[number of VCs per 24 hours / total number of heartbeats per 24 hours\] × 100%).

Secondary Outcome Measures

Name	Time	Method
VC burden reduction	Patients were followed up at 3 months postoperatively to assess recurrence.	Preoperative VC burden \[%\] - postoperative VC burden \[%\].
Total procedure time	From the start to the end of the procedure.	Total procedure time.
Total fluoroscopy time	From the start to the end of the procedure.	Total fluoroscopy time.
Major perioperative complications	30 days postoperatively.	Including cardiac tamponade, atrioventricular block, stroke, or pulmonary embolism.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Xuhui, China