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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• 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) [Срок оценки: 1 year]
• 30 days after surgery: Cardiovascular mortality [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Patients benefited from 1-year overall survival (OS) and progression-free survival (PFS) [Срок оценки: 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 [Срок оценки: 1 year]
• New malignant arrhythmias (persistent ventricular tachycardia or ventricular fibrillation, cardiac arrest, high atrioventricular block) [Срок оценки: 1 year]
• Embolism (including stroke and systemic embolism) [Срок оценки: 1 year]
• Surgery-related organ injury (including cardiac rupture) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xijing Hospital — Сиань

Идентификаторы

NCT: NCT06830512 · KY20232307-F-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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