Echocardiography-guided radiofrequency ablation for cardiac tumors
The Safety and Efficacy Evaluation of Echocardiography-guided Percutaneous Radiofrequency Ablation for Cardiac Tumors: a Single-arm, Prospective, Single-center Clinical Study
This study is testing a new procedure using ultrasound to help treat heart tumors in patients who can't have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT06830512 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of echocardiography-guided percutaneous radiofrequency ablation, known as the Liwen procedure, for treating cardiac tumors. It is a single-arm, prospective study conducted at Xijing Hospital, where patients with symptomatic cardiac tumors that cannot be surgically removed will receive the Liwen procedure. Participants will be monitored through follow-up assessments at various intervals to evaluate outcomes and safety. The study aims to provide an alternative treatment option for patients who are not candidates for traditional surgery.
Who should consider this trial
Good fit: Ideal candidates include patients experiencing hemodynamic changes or significant symptoms due to cardiac tumors who cannot undergo surgical resection.
Not a fit: Patients with severe arrhythmias, other significant heart diseases requiring surgery, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could offer a minimally invasive treatment option for patients with cardiac tumors, potentially improving their quality of life and survival rates.
How similar studies have performed: While the approach of using echocardiography-guided radiofrequency ablation is innovative, similar techniques have shown promise in treating other types of tumors, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shannxi
- Xijing Hospital — Xi'an, Shannxi, China (Recruiting)
Study contacts
- Study coordinator: Liwen Liu
- Email: liuliwen1969@fmmu.edu.cn
- Phone: +86 029 8477 1623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.