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

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 Overview

• Status: Recruiting
• Conditions: Cardiac Tumors
• Intervention / Treatment: Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy; Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University
      • Contact: Liwen Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac tumors	Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy; Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Neoplasms; Neoplasms by Site; Thoracic Neoplasms; Heart Neoplasms
• Other Study ID Numbers: KY20162034-1