Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy (CTIH)

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Cardiac Tumors

Treatments: Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy; Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02815553

KY20162034-1

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cardiac tumors

Experimental group

Treatment:

Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy

Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy