Hypertrophic CardiomyopathyHCMNCT06496633
Echocardiography-guided Percutaneous Septal Radiofrequency Ablation for Obstructive HCM After Alcohol Septal Ablation
An observational study of Hypertrophic Cardiomyopathy, run by Xijing Hospital at 1 site in China.
Trial summary
After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Percutaneous Intramyocardial Septal Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obstructive hypertrophic cardiomyopathy who underwent Liwen surgery at the Multidisciplinary Diagnosis and Treatment and Genetic Counseling Center for Hypertrophic Cardiomyopathy at Xijing Hospital of the Air Force Military Medical University from January 2017 to August 2023, all of whom had a history of alcohol ablation
Who may be able to join
- The patient is at least 18 years of age.
- Hypertrophic cardiomyopathy with alcohol ablation, LVOT pressure difference at rest or after excitation ≥ 50mmHg;
- The clinical symptoms are obvious, fatigue, shortness of breath, exhaustive angina pectoris, syncope, etc. seriously affect the quality of life, and the effect of adequate drug treatment is not good or the side effects of drugs cannot be tolerated;
- After the informed consent of the patient and his family, he voluntarily underwent Liwen surgery.
Who cannot join
- Non-obstructive hypertrophic cardiomyopathy;
- Left ventricular hypertrophy due to secondary causes, such as increased preload, history of taking drugs suspected of causing left ventricular hypertrophy, etc.
- Preoperative complications with other heart diseases require surgical treatment.
- The disease will make it difficult to evaluate treatment (e.g. cancer, severe metabolic diseases, mental illness, etc.).
- Patients who have participated in any clinical trial of drugs and/or medical devices within 1 month before surgery or during follow-up;
- Pregnant and breastfeeding women;
- Patients with poor adherence may not cooperate during treatment or follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Efficacy and Safety of Echocardiography-guided Percutaneous Intraventricular Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy After Alcohol Septal Ablation
After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new minimally invasive treatment for HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery in HOCM patients who failed alcohol ablation and provide new treatment methods for patients.
Read the detailed description
Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiovascular disease, mostly due to mutations in the gene encoding myocardial sarcomere contractile protein, with an incidence of about 1:500-1:200. HCM is the main cause of sudden cardiac death in young people and athletes. Its clinical manifestations are highly heterogeneous. Some patients have no obvious symptoms or mild symptoms, but some patients have obvious myocardial hypertrophy in the early stage, resulting in chest tightness, chest pain, breathing difficulties, syncope, heart failure, and even sudden cardiac death. The annual mortality rate of HCM patients is about 1.4% -2.2%. Alcohol septal ablation (ASA) is a kind of interventional therapy. Its principle is to inject anhydrous alcohol through a catheter, occlude the septal branch of the coronary artery, make the hypertrophic ventricular septal myocardium that dominates it ischemic, necrosis, thinning, and contractility decrease, so that the obstruction of the outflow tract disappears or alleviates, thereby improving the clinical symptoms of patients. However, HOCM patients often have serious clinical symptoms and adverse complications after alcohol ablation, and invasive surgical treatment is required when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new path to treat minimally invasive HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery after alcohol ablation in HOCM patients, and to verify its early postoperative efficacy.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Percutaneous Intramyocardial Septal Radiofrequency Ablation
- Keywords
- Percutaneous Intramyocardial Septal Radiofrequency Ablation, Hypertrophic Cardiomyopathy, Alcohol Septal Ablation
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Intramyocardial Septal Radiofrequency AblationProcedure or surgery
PIMSRA procedure represents a significant breakthrough in the treatment of HOCM patients, as it uses a unique transmyocardial approach to directly and precisely insert a radiofrequency electrode needle into the hypertrophied IVS for targeted ablation
| Study group | Role | What they receive |
|---|---|---|
| cohort :Hypertrophic Cardiomyopathy patients with residual obstruction after Alcohol Septal Ablation | All patients performed procedure of Percutaneous Intramyocardial Septal Radiofrequency Ablation Receives: Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment success rate
For survival, the left ventricular outflow tract pressure gradient (LVOT pressure gradient) decreased by ≥ 50% or the resting left ventricular outflow tract pressure gradient (LVOT pressure gradient) was < 30 mmHg
Measured: Six months after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start26 Mar 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Liwen, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496633
- Sponsor's protocol ID
- KY20242206-C-1
- Acronym
- HCM
- Status last verified
- Mar 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Hsi DH, Ta S, Wang J, Wang B, Ma H, Shan B, Hu R, Li J, Liu L. Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Cardiomyopathy With Residual Obstruction After Alcohol Septal Ablation. Can J Cardiol. 2025 Dec;41(12):2397-2406. doi: 10.1016/j.cjca.2025.08.355. Epub 2025 Sep 25.
PubMed 41015247
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Echocardiography-guided Percutaneous Intraventricular Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy After Alcohol Septal Ablation
- ClinicalTrials.gov ID
- NCT06496633
- Acronym / sponsor ID
- HCM / KY20242206-C-1
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Percutaneous Intramyocardial Septal Radiofrequency Ablation, Hypertrophic Cardiomyopathy, Alcohol Septal Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jul 2024 (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.
After alcohol ablation, some HOCM patients have serious clinical symptoms and adverse complications, and need to undergo invasive surgery again when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new minimally invasive treatment for HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery in HOCM patients who failed alcohol ablation and provide new treatment methods for patients.
Detailed description
Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiovascular disease, mostly due to mutations in the gene encoding myocardial sarcomere contractile protein, with an incidence of about 1:500-1:200. HCM is the main cause of sudden cardiac death in young people and athletes. Its clinical manifestations are highly heterogeneous. Some patients have no obvious symptoms or mild symptoms, but some patients have obvious myocardial hypertrophy in the early stage, resulting in chest tightness, chest pain, breathing difficulties, syncope, heart failure, and even sudden cardiac death. The annual mortality rate of HCM patients is about 1.4% -2.2%. Alcohol septal ablation (ASA) is a kind of interventional therapy. Its principle is to inject anhydrous alcohol through a catheter, occlude the septal branch of the coronary artery, make the hypertrophic ventricular septal myocardium that dominates it ischemic, necrosis, thinning, and contractility decrease, so that the obstruction of the outflow tract disappears or alleviates, thereby improving the clinical symptoms of patients. However, HOCM patients often have serious clinical symptoms and adverse complications after alcohol ablation, and invasive surgical treatment is required when adequate drug therapy is not effective or cannot tolerate the side effects of drugs. Liwen surgery is a safe and effective new path to treat minimally invasive HOCM patients, so the purpose of this study was to evaluate the safety and efficacy of Liwen surgery after alcohol ablation in HOCM patients, and to verify its early postoperative efficacy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort :Hypertrophic Cardiomyopathy patients with residual obstruction after Alcohol Septal Ablation | – | Procedure: Percutaneous Intramyocardial Septal Radiofrequency AblationAll patients performed procedure of Percutaneous Intramyocardial Septal Radiofrequency Ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obstructive hypertrophic cardiomyopathy who underwent Liwen surgery at the Multidisciplinary Diagnosis and Treatment and Genetic Counseling Center for Hypertrophic Cardiomyopathy at Xijing Hospital of the Air Force Military Medical University from January 2017 to August 2023, all of whom had a history of alcohol ablation
Key inclusion criteria (4 listed)
- The patient is at least 18 years of age.
- Hypertrophic cardiomyopathy with alcohol ablation, LVOT pressure difference at rest or after excitation ≥ 50mmHg;
- The clinical symptoms are obvious, fatigue, shortness of breath, exhaustive angina pectoris, syncope, etc. seriously affect the quality of life, and the effect of adequate drug treatment is not good or the side effects of drugs cannot be tolerated;
- After the informed consent of the patient and his family, he voluntarily underwent Liwen surgery.
Key exclusion criteria (7 listed)
- Non-obstructive hypertrophic cardiomyopathy;
- Left ventricular hypertrophy due to secondary causes, such as increased preload, history of taking drugs suspected of causing left ventricular hypertrophy, etc.
- Preoperative complications with other heart diseases require surgical treatment.
- The disease will make it difficult to evaluate treatment (e.g. cancer, severe metabolic diseases, mental illness, etc.).
- Patients who have participated in any clinical trial of drugs and/or medical devices within 1 month before surgery or during follow-up;
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 |
|---|---|---|
| Percutaneous Intramyocardial Septal Radiofrequency AblationPIMSRA procedure represents a significant breakthrough in the treatment of HOCM patients, as it uses a unique transmyocardial approach to directly and precisely insert a radiofrequency electrode needle into the hypertrophied IVS for targeted ablation | Procedure or surgery | cohort :Hypertrophic Cardiomyopathy patients with residual obstruction after Alcohol Septal Ablation |
Primary outcome
treatment success rate
Time frame: Six months after procedure.
For survival, the left ventricular outflow tract pressure gradient (LVOT pressure gradient) decreased by ≥ 50% or the resting left ventricular outflow tract pressure gradient (LVOT pressure gradient) was < 30 mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 41015247Zhang J, Hsi DH, Ta S, Wang J, Wang B, Ma H, Shan B, Hu R, Li J, Liu L. Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Cardiomyopathy With Residual Obstruction After Alcohol Septal Ablation. Can J Cardiol. 2025 Dec;41(12):2397-2406. doi: 10.1016/j.cjca.2025.08.355. Epub 2025 Sep 25.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment success rate (time frame: Six months after procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496633, which also lists 1 linked publication.
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 11 Jul 2024.