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

NCT06898281 | Active Not Recruiting DMC

• 1 other identifier: ICE-PMPVC
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ventricular Contractions

Keywords

intracardiac echocardiography; papillary muscle-originating premature ventricular contractions; premature ventricular contractions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• VC burden reduction

  Patients were followed up at 3 months postoperatively to assess recurrence.

• Total procedure time

  From the start to the end of the procedure.

• Total fluoroscopy time

  From the start to the end of the procedure.

• Major perioperative complications

  30 days postoperatively.

Study Arms (2)

intracardiac echocardiography (ICE)-guided catheter ablation

EXPERIMENTAL

Intracardiac echocardiography (ICE)-guided catheter ablation.

Procedure: intracardiac echocardiography (ICE)-guided catheter ablation

Pressure-sensing catheter ablation alone

ACTIVE COMPARATOR

Pressure-sensing catheter ablation alone.

Procedure: Pressure-sensing catheter ablation alone

Interventions

intracardiac echocardiography (ICE)-guided catheter ablation PROCEDURE

Intracardiac echocardiography (ICE)-guided catheter ablation.

intracardiac echocardiography (ICE)-guided catheter ablation

Pressure-sensing catheter ablation alone PROCEDURE

Pressure-sensing catheter ablation alone

Pressure-sensing catheter ablation alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Xuhui, 200030, China

Location

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 27, 2025
• Study Start: March 23, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-03

Locations

CN (1)