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

Effectiveness and Safety of Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Premature Ventricular Contractions
• Intervention / Treatment: Procedure: intracardiac echocardiography (ICE)-guided catheter ablation; Procedure: Pressure-sensing catheter ablation alone

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xuhui
    • Shanghai, Xuhui, China, 200030
      • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intracardiac echocardiography (ICE)-guided catheter ablation; Intracardiac echocardiography (ICE)-guided catheter ablation.	Procedure: intracardiac echocardiography (ICE)-guided catheter ablation; Intracardiac echocardiography (ICE)-guided catheter ablation.
Active Comparator: Pressure-sensing catheter ablation alone; Pressure-sensing catheter ablation alone.	Procedure: Pressure-sensing catheter ablation alone; Pressure-sensing catheter ablation alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from VC 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%).	Patients were followed up at 3 months postoperatively to assess recurrence.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: Qilu Hospital of Shandong University; Fujian Medical University Union Hospital; The First People's Hospital of Hefei; Shenzhen Fuwai Hospital,Chinese Academy of Medical Sciences; The Second People's Hospital of Anhui Province

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: March 22, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: intracardiac echocardiography; premature ventricular contractions; papillary muscle-originating premature ventricular contractions
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Urogenital Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Premature Birth; Ventricular Premature Complexes
• Other Study ID Numbers: ICE-PMPVC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No