Heart NeoplasmsNCT06830512
The Safety and Efficacy Evaluation of Echocardiography-guided Percutaneous Radiofrequency Ablation for Cardiac Tumors: a Single-arm, Prospective, Single-center Clinical Study
A study testing Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors in people with Heart Neoplasms, run by Xijing Hospital at 1 site in China.
Trial summary
The safety and efficacy evaluation of echocardiography-guided percutaneous radiofrequency ablation (Liwen prcocedure) for cardiac tumors: a single-arm, prospective, single-center clinical study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Neoplasms
- What is being tested?
- Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hemodynamic changes caused by cardiac tumors or patients with obvious clinical symptoms such as chest tightness, shortness of breath, palpitations, etc., or the risk of embolization of intracardial tumors;
- Patients who cannot be completely excised by surgery, cannot tolerate surgery or refuse surgery;
- The patient was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed the informed consent, and agreed to complete the follow-up and follow-up examination required.
Who cannot join
- Previously documented persistent ventricular tachycardia or ventricular fibrillation, supraventricular tachycardia with hemodynamic disturbance, cardiac arrest, and high atrioventricular block;
- Previous history of tumor or thromboembolism exfoliating organ embolism;
- Combined with other heart diseases requiring surgical treatment;
- Active infections should be treated with antibiotics;
- Bleeding constitution and coagulation disorders, or anticoagulation, antiplatelet therapy contraindications;
- Patients who are pregnant, breastfeeding or planning to become pregnant during the clinical study;
Show all 12Show fewer
- The disease will cause difficulties in the evaluation of treatment, such as mental illness, metabolic disease, etc.;
- Patients who cannot tolerate general anesthesia;
- Severe liver, kidney, lung, brain and other major organ failure;
- There are no patients who are suitable for the injection path of Liwen operation;
- Other diseases deemed unsuitable for inclusion by the researchers;
- The researcher judged that the patients' dependence was poor and could not complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shannxi, 710032
Chao Han, +86 029 8477 1623, hanchao@fmmu.edu.cn
About this study
The safety and efficacy evaluation of echocardiography-guided percutaneous radiofrequency ablation (Liwen prcocedure) for cardiac tumors: a single-arm, prospective, single-center clinical study.
Read the detailed description
Cardiac tumor is a rare disease in clinical practice, which is divided into primary cardiac tumor and secondary cardiac tumor, of which secondary cardiac tumor is about 20 to 40 times of primary.The clinical symptoms of cardiac tumors are complex and varied, mainly related to the size and location of tumors. Tumors often lead to blood flow obstruction, arrhythmia, systemic embolism, which seriously threaten the life of patients.At present, surgical resection is the only operation treatment. However, many cardiac tumors have lost the chance of surgery because of many reasons.
Based on previous work, we found echocardiography-guided percutaneous radiofrequency ablation (Liwen procedure) to treat cardiac tumors.This is a single-arm, prospective, single-center clinical study. After signing the informed consent letter, the patients were screened to meet the enrollment conditions and were treated with Liwen procedure for cardiac tumors. Follow-up was performed at 7 days, 30 days, 3 months, 6 months and 12 months.
- Conditions
- Heart Neoplasms
- Being tested
- Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors
- Keywords
- cardiac tumors；echocardiography-guided percutaneous radiofrequency ablation; safety; efficacy
- Medical subject headings
- Heart Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumorsProcedure or surgery
In the parasternal long-axis section, the cardiac puncture guide line was used to locate the puncture, and the best puncture path through the chest wall was selected. The coaxial biopsy needle was punctured through the guide frame, and then through the skin and subcutaneous tissue into the heart tumor tissue to take 2-10 biopsy samples, which were sent for pathological examination. The biopsy needle was extracted, and the radiofrequency electrode needle was punctured along the coaxial sheath to the planned ablation site of the heart tumor. The radiofrequency ablation device was started and the ablation treatment was performed.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Echocardiography-guided percutaneous radiofrequency ablation Receives: Procedure: Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective response rate (Effective defined as ≥30% reduction in the total longest diameter of the target lesion first detected during the postoperative follow-up period and confirmed 4 weeks after surgery)
Measured: 1 year
30 days after surgery: Cardiovascular mortality
Measured: 1 year
Secondary outcomes (5)
Patients benefited from 1-year overall survival (OS) and progression-free survival (PFS)
Measured: 1 year
Arrhythmia, hemodynamics, cardiac function rating (NYHA rating), and quality of life (QLQ-C30 score) were improved at 3, 6, and 12 months after surgery
Measured: 1 year
New malignant arrhythmias (persistent ventricular tachycardia or ventricular fibrillation, cardiac arrest, high atrioventricular block)
Measured: 1 year
Embolism (including stroke and systemic embolism)
Measured: 1 year
Surgery-related organ injury (including cardiac rupture)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start24 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart NeoplasmsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830512
- Sponsor's protocol ID
- KY20232307-F-2
- Status last verified
- Mar 2024
- First submitted
- 7 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Evaluation of Echocardiography-guided Percutaneous Radiofrequency Ablation for Cardiac Tumors: a Single-arm, Prospective, Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT06830512
- Acronym / sponsor ID
- KY20232307-F-2
- Conditions
- Heart Neoplasms
- Keywords
- cardiac tumors；echocardiography-guided percutaneous radiofrequency ablation; safety; efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy evaluation of echocardiography-guided percutaneous radiofrequency ablation (Liwen prcocedure) for cardiac tumors: a single-arm, prospective, single-center clinical study.
Detailed description
Cardiac tumor is a rare disease in clinical practice, which is divided into primary cardiac tumor and secondary cardiac tumor, of which secondary cardiac tumor is about 20 to 40 times of primary.The clinical symptoms of cardiac tumors are complex and varied, mainly related to the size and location of tumors. Tumors often lead to blood flow obstruction, arrhythmia, systemic embolism, which seriously threaten the life of patients.At present, surgical resection is the only operation treatment. However, many cardiac tumors have lost the chance of surgery because of many reasons.
Based on previous work, we found echocardiography-guided percutaneous radiofrequency ablation (Liwen procedure) to treat cardiac tumors.This is a single-arm, prospective, single-center clinical study. After signing the informed consent letter, the patients were screened to meet the enrollment conditions and were treated with Liwen procedure for cardiac tumors. Follow-up was performed at 7 days, 30 days, 3 months, 6 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Procedure: Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumorsEchocardiography-guided percutaneous radiofrequency ablation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hemodynamic changes caused by cardiac tumors or patients with obvious clinical symptoms such as chest tightness, shortness of breath, palpitations, etc., or the risk of embolization of intracardial tumors;
- Patients who cannot be completely excised by surgery, cannot tolerate surgery or refuse surgery;
- The patient was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed the informed consent, and agreed to complete the follow-up and follow-up examination required.
Key exclusion criteria (12 listed)
- Previously documented persistent ventricular tachycardia or ventricular fibrillation, supraventricular tachycardia with hemodynamic disturbance, cardiac arrest, and high atrioventricular block;
- Previous history of tumor or thromboembolism exfoliating organ embolism;
- Combined with other heart diseases requiring surgical treatment;
- Active infections should be treated with antibiotics;
- Bleeding constitution and coagulation disorders, or anticoagulation, antiplatelet therapy contraindications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumorsIn the parasternal long-axis section, the cardiac puncture guide line was used to locate the puncture, and the best puncture path through the chest wall was selected. The coaxial biopsy needle was punctured through the guide frame, and then through the skin and subcutaneous tissue into the heart tumor tissue to take 2-10 biopsy samples, which were sent for pathological examination. The biopsy needle was extracted, and the radiofrequency electrode needle was punctured along the coaxial sheath to the planned ablation site of the heart tumor. The radiofrequency ablation device was started and the ablation treatment was performed. | Procedure or surgery | treatment group |
Primary outcome
Effective response rate (Effective defined as ≥30% reduction in the total longest diameter of the target lesion first detected during the postoperative follow-up period and confirmed 4 weeks after surgery)
Time frame: 1 year
30 days after surgery: Cardiovascular mortality
Time frame: 1 year
5 secondary outcomes
Patients benefited from 1-year overall survival (OS) and progression-free survival (PFS)
Time frame: 1 year
Arrhythmia, hemodynamics, cardiac function rating (NYHA rating), and quality of life (QLQ-C30 score) were improved at 3, 6, and 12 months after surgery
Time frame: 1 year
New malignant arrhythmias (persistent ventricular tachycardia or ventricular fibrillation, cardiac arrest, high atrioventricular block)
Time frame: 1 year
Embolism (including stroke and systemic embolism)
Time frame: 1 year
Surgery-related organ injury (including cardiac rupture)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Neoplasms
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography-guided percutaneous radiofrequency ablation for cardiac tumors in people with Heart Neoplasms, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liwen Liu (+86 029 8477 1623, liuliwen1969@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective response rate (Effective defined as ≥30% reduction in the total longest diameter of the target lesion first detected during the postoperative follow-up period and confirmed 4 weeks after surgery) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.