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

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ClinicalTrials.gov Identifier: NCT02815553
Recruitment Status : Unknown
Verified May 2016 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.


Condition or disease Intervention/treatment Phase
Cardiac Tumors Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardiac tumors Procedure: Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy
Procedure: Direct Transthoracic Cardiac Tumor Laser Ablation Therapy



Primary Outcome Measures :
  1. Mortality [ Time Frame: 24 months ]
  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Quantification of lung function [ Time Frame: 24 months ]
    Investigators use diffusion function to quantify the lung function.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 18 years old

Exclusion Criteria:

  • Subject has cerebrovascular diseases
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815553


Contacts
Contact: Liwen Liu, MD 86-13571975528 liuliwencrt@hotmail.com

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

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02815553     History of Changes
Other Study ID Numbers: KY20162034-1
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Heart Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Heart Diseases
Cardiovascular Diseases