Hypertrophic Obstructive Cardiomyopathy (HOCM)NCT06277960
Septal Ablation for Obstructive HCM
A study testing percutaneous intramyocardial septal radiofrequency ablation system in people with Hypertrophic Obstructive Cardiomyopathy (HOCM), run by SuZhou Sinus Medical Technologies Co.,Ltd at 1 site in China.
Trial summary
Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy (HOCM)
- What is being tested?
- percutaneous intramyocardial septal radiofrequency ablation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 30 Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 75 years old, no gender limit.
- Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic Anterior Motion）in the resting-state or after exercise stress test.
- Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
- Subject with adequate drug treatment is not effective or cannot tolerate side effects of the drug.
- Subject was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed an ethics committee-approved informed consent form before conducting any special examinations and/or treatments related to the clinical study.
Who cannot join
- Subject is pregnant, lactating, or planned to conceive during a clinical study.
- Subject with interventricular septal thickness ≥ 30mm.
- Subject has undergone other ventricular septal volume reduction surgeries.
- Subject with complete right bundle branch block on electrocardiogram.
- Subject with Sudden Cardiac Death Index ≥ 10%.
- Subject combined with other heart diseases requires surgical treatment.
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- Subject with heart failure(Defined as resting heart failure after intensive anti-heart failure therapy, left ventricular fraction of ejecting< 40%).
- Subject is mentally incapacitated or unable to understand the study requirements.
- Subject has participated in other clinical trials within 3 months.
- The investigator determines that there is any situation that affects the safety of the subjects or interferes with the evaluation of test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Safety and Effectiveness of Percutaneous Intramyocardial Septal Radiofrequency Ablation System in the Treatment of Hypertrophic Obstructive Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.
Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.
The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy.
- Being tested
- percutaneous intramyocardial septal radiofrequency ablation system
- 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 ablation systemDevice
The device is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous intramyocardial septal radiofrequency ablation system | Experimental | Not described Receives: Device: percutaneous intramyocardial septal radiofrequency ablation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day major adverse clinical events (MACE)
30-day major adverse clinical events (MACE), including death, emergency surgery, severe pericardial effusion bleeding requiring pericardiocentesis or surgery, atrioventricular block, heart perforation, and surgery-related stroke.
Measured: 30-day
Secondary outcomes (5)
Technical success rate
Technical success rate: the radiofrequency ablation catheter reaches the required treatment site, successfully completes the ablation, and is successfully withdrawn from the body.
Measured: 30-day
Short Form 36 (SF-36) health survey questionnaire
The life quality score of SF-36 would significantly improved after the procedure. The higher scores mean a better outcome.
Measured: 90-day
Improvement of left ventricular outflow tract gradient (LVOTG)
The improvement of LVOTG at post-procedure,30 days,3 months and 6 months after procedure. If the pressure gradient is reduced, the symptom will improve.
Measured: 6 months
Improvement of NYHA functional classification
The improvement of NYHA functional class at post-procedure,30 days,3 months and 6 months after procedure. The lower class mean a better outcome.
Measured: 6 months
6-min walk distance
The increase of 6-min walk distance at post-procedure,30 days,3 months and 6 months after procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start28 Mar 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive Cardiomyopathy (HOCM)Studies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277960
- Sponsor's protocol ID
- CNS2301
- Status last verified
- May 2025
- First submitted
- 27 Jan 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-arm Clinical Study to Evaluate the Safety and Effectiveness of Percutaneous Intramyocardial Septal Radiofrequency Ablation System in the Treatment of Hypertrophic Obstructive Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06277960
- Acronym / sponsor ID
- CNS2301
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SuZhou Sinus Medical Technologies Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Feb 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.
Hypertrophic cardiomyopathy (HCM) is a common clinical genetic-related disease, with a global incidence of 0.2%-0.5%, but only a few cases (10-20%) have been clinically diagnosed. About 70% of them are hypertrophic obstructive cardiomyopathy (HOCM), these HOCM patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, percutaneous transluminal septal myocardial ablation(PTSMA), percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) and percutaneous endocardial septal radiofrequency ablation (PESA) is introduced to patients with refractory symptoms or drug resistance. However, surgical operations are complicated and high risk procedures with high mortality. Interventional approaches are very difficult to perform and therefore the application is limited.
Previous researches have shown that interventricular septal radiofrequency ablation could effectively reduce the left ventricular outflow tract pressure gradient (LVOTG), thereby treating obstructive hypertrophic cardiomyopathy (HOCM). This device is based on the same radiofrequency ablation energy principle, however, the catheter is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum, which is potentially a lower risk route of access for septal ablation than currently attempted interventional approaches.
The purpose of this study is to evaluate the safety and efficacy of percutaneous intramyocardial septal ablation catheters in the treatment of obstructive hypertrophic cardiomyopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| percutaneous intramyocardial septal radiofrequency ablation system | Experimental | Device: percutaneous intramyocardial septal radiofrequency ablation system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old ≤ age ≤ 75 years old, no gender limit.
- Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic Anterior Motion）in the resting-state or after exercise stress test.
- Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
- Subject with adequate drug treatment is not effective or cannot tolerate side effects of the drug.
- Subject was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed an ethics committee-approved informed consent form before conducting any special examinations and/or treatments related to the clinical study.
Key exclusion criteria (10 listed)
- Subject is pregnant, lactating, or planned to conceive during a clinical study.
- Subject with interventricular septal thickness ≥ 30mm.
- Subject has undergone other ventricular septal volume reduction surgeries.
- Subject with complete right bundle branch block on electrocardiogram.
- Subject with Sudden Cardiac Death Index ≥ 10%.
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 ablation systemThe device is introduced into the right ventricle and performs ablation treatment on the hypertrophic interventricular septum. | Device | percutaneous intramyocardial septal radiofrequency ablation system |
Primary outcome
30-day major adverse clinical events (MACE)
Time frame: 30-day
30-day major adverse clinical events (MACE), including death, emergency surgery, severe pericardial effusion bleeding requiring pericardiocentesis or surgery, atrioventricular block, heart perforation, and surgery-related stroke.
5 secondary outcomes
Technical success rate
Time frame: 30-day
Short Form 36 (SF-36) health survey questionnaire
Time frame: 90-day
Improvement of left ventricular outflow tract gradient (LVOTG)
Time frame: 6 months
Improvement of NYHA functional classification
Time frame: 6 months
6-min walk distance
Time frame: 6 months
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 30 May 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing percutaneous intramyocardial septal radiofrequency ablation system in people with Hypertrophic Obstructive Cardiomyopathy (HOCM), run by SuZhou Sinus Medical Technologies Co.,Ltd 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 30 May 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?
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?
30-day major adverse clinical events (MACE) (time frame: 30-day). 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 30 May 2025.