Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy

NCT ID: NCT02815553

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-08-31

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.

Conditions

Cardiac Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiac tumors

Group Type: EXPERIMENTAL

Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy

Intervention Type: PROCEDURE

Direct Transthoracic Cardiac Tumor Laser Ablation Therapy

Intervention Type: PROCEDURE

Interventions

Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy

Intervention Type: PROCEDURE

Direct Transthoracic Cardiac Tumor Laser Ablation Therapy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Liwen

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liwen Liu, MD

Role: CONTACT

liuliwencrt@hotmail.com

86-13571975528

Facility Contacts

Liwen Liu, MD

Role: primary

References

Huang J, Lei C, Hsi DH, Zheng M, Ma H, Ta S, Hu R, Han C, Li W, Li J, Qu D, Ruan F, Wang J, Wang B, Zhao X, Liu J, Zhao L, Wang Z, Yang J, Liu L. Echocardiography-Guided Radiofrequency Ablation for Cardiac Tumors. JACC CardioOncol. 2024 Apr 30;6(4):560-571. doi: 10.1016/j.jaccao.2024.03.008. eCollection 2024 Aug.

Reference Type: DERIVED

PMID: 39239332 (View on PubMed)

Other Identifiers

KY20162034-1

Identifier Type: -

Identifier Source: org_study_id