Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy

Xijing Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Tumors

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mortality

Time frame: 24 months

Tumor size

If the maximum tumor size increases, the symptom gets deteriorated; If the maximum tumor size decreases, the symptom gets relieved.

Time frame: 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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 24 months

Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts