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NCT Number: NCT06898281

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, Xuhui, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intracardiac echocardiography (ICE)-guided catheter ablation

Procedure

Intracardiac echocardiography (ICE)-guided catheter ablation.

Pressure-sensing catheter ablation alone

Procedure

Pressure-sensing catheter ablation alone

Primary outcomes

  1. Freedom from VC recurrence

    Time frame: 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 outcomes

  1. VC burden reduction

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

    Preoperative VC burden [%] - postoperative VC burden [%].

  2. Total procedure time

    Time frame: From the start to the end of the procedure.

    Total procedure time.

  3. Total fluoroscopy time

    Time frame: From the start to the end of the procedure.

    Total fluoroscopy time.

  4. Major perioperative complications

    Time frame: 30 days postoperatively.

    Including cardiac tamponade, atrioventricular block, stroke, or pulmonary embolism.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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