Clinical Trial: Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary:

Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, malignant 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) and 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.

Detailed Summary:
Sponsor: Xijing Hospital

Current Primary Outcome:

• Mortality [ Time Frame: 24 months ]
• Tumor size [ Time Frame: 24 months ]
  If the maximum tumor size increases, the symptom gets deteriorated; If the maximum tumor size decreases, the symptom gets relieved.
• Quantification of obstructive severity [ Time Frame: 24 months ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quantification of lung function [ Time Frame: 24 months ]
  Investigators use diffusion function to quantify the lung function.
• Quantification of cardiac function [ Time Frame: 24 months ]
  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.
• Quantification of tumor blood perfusion [ Time Frame: 24 months ]
  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.

Original Secondary Outcome: Same as current

Information By: Xijing Hospital

Dates:
Date Received: May 27, 2016
Date Started: April 2016
Date Completion:
Last Updated: June 23, 2016
Last Verified: May 2016