The Safety and Efficacy Evaluation of Echocardiography-guided Percutaneous Radiofrequency Ablation for Cardiac Tumors: a Single-arm, Prospective, Single-center Clinical Study

NCT06830512 | Recruiting

• 1 other identifier: KY20232307-F-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The safety and efficacy evaluation of echocardiography-guided percutaneous radiofrequency ablation (Liwen prcocedure) for cardiac tumors: a single-arm, prospective, single-center clinical study.

Conditions

Heart Neoplasms

Keywords

cardiac tumors；echocardiography-guided percutaneous radiofrequency ablation; safety; efficacy

Outcome Measures

Primary Outcomes (2)

• Effective response rate (Effective defined as ≥30% reduction in the total longest diameter of the target lesion first detected during the postoperative follow-up period and confirmed 4 weeks after surgery)

  1 year

• 30 days after surgery: Cardiovascular mortality

  1 year

Secondary Outcomes (5)

• Patients benefited from 1-year overall survival (OS) and progression-free survival (PFS)

  1 year

• Arrhythmia, hemodynamics, cardiac function rating (NYHA rating), and quality of life (QLQ-C30 score) were improved at 3, 6, and 12 months after surgery

  1 year

• New malignant arrhythmias (persistent ventricular tachycardia or ventricular fibrillation, cardiac arrest, high atrioventricular block)

  1 year

• Embolism (including stroke and systemic embolism)

  1 year

• Surgery-related organ injury (including cardiac rupture)

  1 year

Study Arms (1)

treatment group

EXPERIMENTAL

Echocardiography-guided percutaneous radiofrequency ablation

Procedure: Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors

Interventions

Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors PROCEDURE

In the parasternal long-axis section, the cardiac puncture guide line was used to locate the puncture, and the best puncture path through the chest wall was selected. The coaxial biopsy needle was punctured through the guide frame, and then through the skin and subcutaneous tissue into the heart tumor tissue to take 2-10 biopsy samples, which were sent for pathological examination. The biopsy needle was extracted, and the radiofrequency electrode needle was punctured along the coaxial sheath to the planned ablation site of the heart tumor. The radiofrequency ablation device was started and the ablation treatment was performed.

treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemodynamic changes caused by cardiac tumors or patients with obvious clinical symptoms such as chest tightness, shortness of breath, palpitations, etc., or the risk of embolization of intracardial tumors;
• Patients who cannot be completely excised by surgery, cannot tolerate surgery or refuse surgery;
• The patient was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed the informed consent, and agreed to complete the follow-up and follow-up examination required.

You may not qualify if:

• Previously documented persistent ventricular tachycardia or ventricular fibrillation, supraventricular tachycardia with hemodynamic disturbance, cardiac arrest, and high atrioventricular block;
• Previous history of tumor or thromboembolism exfoliating organ embolism;
• Combined with other heart diseases requiring surgical treatment;
• Active infections should be treated with antibiotics;
• Bleeding constitution and coagulation disorders, or anticoagulation, antiplatelet therapy contraindications;
• Patients who are pregnant, breastfeeding or planning to become pregnant during the clinical study;
• The disease will cause difficulties in the evaluation of treatment, such as mental illness, metabolic disease, etc.;
• Patients who cannot tolerate general anesthesia;
• Severe liver, kidney, lung, brain and other major organ failure;
• There are no patients who are suitable for the injection path of Liwen operation;
• The researcher judged that the patients' dependence was poor and could not complete the study.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shannxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Heart Neoplasms

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Liwen Liu

CONTACT

+86 029 8477 1623; liuliwen1969@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 17, 2025
• Study Start: January 24, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 17, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)