The safety and efficacy evaluation of echocardiography-guided percutaneous radiofrequency ablation (Liwen prcocedure) for cardiac tumors: a single-arm, prospective, single-center clinical study.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Xijing Hospital
Xi'an, Shannxi, China
RECRUITINGEffective 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)
Time frame: 1 year
30 days after surgery: Cardiovascular mortality
Time frame: 1 year
Patients benefited from 1-year overall survival (OS) and progression-free survival (PFS)
Time frame: 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
Time frame: 1 year
New malignant arrhythmias (persistent ventricular tachycardia or ventricular fibrillation, cardiac arrest, high atrioventricular block)
Time frame: 1 year
Embolism (including stroke and systemic embolism)
Time frame: 1 year
Surgery-related organ injury (including cardiac rupture)
Time frame: 1 year
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