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

NCT ID: NCT06898281

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-23

Study Completion Date

2026-03-01

Brief Summary

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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

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Conditions

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Premature Ventricular Contractions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intracardiac echocardiography (ICE)-guided catheter ablation

Intracardiac echocardiography (ICE)-guided catheter ablation.

Group Type EXPERIMENTAL

intracardiac echocardiography (ICE)-guided catheter ablation

Intervention Type PROCEDURE

Intracardiac echocardiography (ICE)-guided catheter ablation.

Pressure-sensing catheter ablation alone

Pressure-sensing catheter ablation alone.

Group Type ACTIVE_COMPARATOR

Pressure-sensing catheter ablation alone

Intervention Type PROCEDURE

Pressure-sensing catheter ablation alone

Interventions

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intracardiac echocardiography (ICE)-guided catheter ablation

Intracardiac echocardiography (ICE)-guided catheter ablation.

Intervention Type PROCEDURE

Pressure-sensing catheter ablation alone

Pressure-sensing catheter ablation alone

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second People's Hospital of Anhui Province

OTHER

Sponsor Role collaborator

The First People's Hospital of Hefei

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, Xuhui, China

Site Status

Countries

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China

Other Identifiers

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ICE-PMPVC

Identifier Type: -

Identifier Source: org_study_id

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