About this trial
The safety and efficacy evaluation of echocardiography-guided percutaneous radiofrequency ablation (Liwen prcocedure) for cardiac tumors: a single-arm, prospective, single-center clinical study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors
Procedure/SurgeryIn 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 groups
Trial outcomes
Primary outcomes
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)
30 days after surgery: Cardiovascular mortality
Secondary outcomes
Patients benefited from 1-year overall survival (OS) and progression-free survival (PFS)
Arrhythmia, hemodynamics, cardiac function rating (NYHA rating), and quality of life (QLQ-C30 score) were improved at 3, 6, and 12 months after surgery
New malignant arrhythmias (persistent ventricular tachycardia or ventricular fibrillation, cardiac arrest, high atrioventricular block)
Embolism (including stroke and systemic embolism)
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