The Safety and Efficacy Evaluation of Echocardiography-guided Percutaneous Radiofrequency Ablation for Cardiac Tumors: a Single-arm, Prospective, Single-center Clinical Study
Xijing Hospital
40 participants
Jan 24, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria12
- 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;
- Other diseases deemed unsuitable for inclusion by the researchers;
- The researcher judged that the patients' dependence was poor and could not complete the study.
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Interventions
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.
Locations(1)
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NCT06830512