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

Primary Purpose

Cardiac Tumors

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy
Direct Transthoracic Cardiac Tumor Laser Ablation Therapy
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Tumors

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac tumors

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 27, 2016
Last Updated
August 25, 2022
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02815553
Brief Title
Cardiac Tumors Interventional (Radio Frequency/Laser Ablation)Therapy
Acronym
CTIH
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac tumors
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy
Intervention Type
Procedure
Intervention Name(s)
Direct Transthoracic Cardiac Tumor Laser Ablation Therapy
Primary Outcome Measure Information:
Title
Mortality
Time Frame
24 months
Title
Tumor size
Description
If the maximum tumor size increases, the symptom gets deteriorated; If the maximum tumor size decreases, the symptom gets relieved.
Time Frame
24 months
Title
Quantification of obstructive severity
Description
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 Outcome Measure Information:
Title
Quantification of cardiac function
Description
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
Title
Quantification of tumor blood perfusion
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liwen Liu, MD
Phone
86-13571975528
Email
liuliwencrt@hotmail.com
Facility Information:
Facility Name
Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liwen Liu, MD

12. IPD Sharing Statement

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Cardiac Tumors Interventional (Radio Frequency/Laser Ablation)Therapy

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