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

NCT ID: NCT06830512

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-24
• Study Completion Date: 2026-12-30

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.

Detailed Description

Cardiac tumor is a rare disease in clinical practice, which is divided into primary cardiac tumor and secondary cardiac tumor, of which secondary cardiac tumor is about 20 to 40 times of primary.The clinical symptoms of cardiac tumors are complex and varied, mainly related to the size and location of tumors. Tumors often lead to blood flow obstruction, arrhythmia, systemic embolism, which seriously threaten the life of patients.At present, surgical resection is the only operation treatment. However, many cardiac tumors have lost the chance of surgery because of many reasons.

Based on previous work, we found echocardiography-guided percutaneous radiofrequency ablation (Liwen procedure) to treat cardiac tumors.This is a single-arm, prospective, single-center clinical study. After signing the informed consent letter, the patients were screened to meet the enrollment conditions and were treated with Liwen procedure for cardiac tumors. Follow-up was performed at 7 days, 30 days, 3 months, 6 months and 12 months.

Conditions

Heart Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

Echocardiography-guided percutaneous radiofrequency ablation

Group Type: EXPERIMENTAL

Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors

Intervention Type: 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.

Interventions

Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Patients who cannot be completely excised by surgery, cannot tolerate surgery or refuse surgery;

3. 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.

Exclusion Criteria

1. Previously documented persistent ventricular tachycardia or ventricular fibrillation, supraventricular tachycardia with hemodynamic disturbance, cardiac arrest, and high atrioventricular block;

2. Previous history of tumor or thromboembolism exfoliating organ embolism;

3. Combined with other heart diseases requiring surgical treatment;

4. Active infections should be treated with antibiotics;

5. Bleeding constitution and coagulation disorders, or anticoagulation, antiplatelet therapy contraindications;

6. Patients who are pregnant, breastfeeding or planning to become pregnant during the clinical study;

7. The disease will cause difficulties in the evaluation of treatment, such as mental illness, metabolic disease, etc.;

8. Patients who cannot tolerate general anesthesia;

9. Severe liver, kidney, lung, brain and other major organ failure;

10. There are no patients who are suitable for the injection path of Liwen operation;

11. Other diseases deemed unsuitable for inclusion by the researchers;

12. The researcher judged that the patients' dependence was poor and could not complete the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital

Xi'an, Shannxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liwen Liu

Role: CONTACT

liuliwen1969@fmmu.edu.cn

+86 029 8477 1623

Facility Contacts

Chao Han

Role: primary

hanchao@fmmu.edu.cn

+86 029 8477 1623

Other Identifiers

KY20232307-F-2

Identifier Type: -

Identifier Source: org_study_id