Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy

Study Overview
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Brief Summary
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Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, part of tumors are hard to completely resect. Also, as thoracoscopic surgeries induce great operation trauma, some patients cannot tolerate or do not will to take the operation. Therefore, new methods and techniques are in urgent need. Our center have a 12-year experience of intervention treatment for solid tumors and has conducted several animal experiments to verify the effectiveness of transthoracic puncture ablation and radiofrequency ablation for ventricular muscle. The purpose of this study is to conduct new method of direct transthoracic cardiac tumor-targeted Radiofrequency Ablation (RFA) or Laser induced Interstitial Thermotherapy (LITT), make minimally invasive treatment plans for cardiac tumor patients, and verify the safety and validity of intervention treatment in long term.

Conditions
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Cardiac Tumors

Intervention / Treatment
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* Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy
* Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac tumors not suitable for surgical removal Subject has significant clinical symptoms or obstruction (or progressive obstruction increase) in inflow or outflow tracts shown in imaging evidence Cardiac tumors in ventricular chambers, myocardium, or pericardium Subject who cannot tolerate thoracoscopic removal or volunteer for the operation Subject Over 12 years old Exclusion Criteria: Subject who has other cardiac diseases must receive surgical removal Subject has end-stage heart failure Subject has poor physical conditions and cannot tolerate the operation

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac tumors<br> | Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy<br> <br> Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 24 months | 
| Tumor size | If the maximum tumor size increases, the symptom gets deteriorated; If the maximum tumor size decreases, the symptom gets relieved. | 24 months | 
| Quantification of obstructive severity | Investigators use the peak velocity and of stenosis (by echocardiography) to quantify obstructive severity caused by the tumor. If the peak velocity increases, the symptom gets deteriorated; if the peak velocity decreases, the symptom gets relieved. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of cardiac function | Investigators use ejection fraction(EF) to quantify the cardiac function. If EF is higher after the operation, the cardiac function gets recovered; if EF is lower after the operation,the cardiac function does't get recovered. | 24 months | 
| Quantification of tumor blood perfusion | Investigators use contrast-enhanced ultrasonography to quantify tumor blood perfusion. If there is no perfusion observed, the therapy is successful；if there is perfusion, the therapy is ineffective. | 24 months |