Hypertrophic Cardiomyopathy, ObstructiveREFINE-HCMNCT07006493
REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
A study testing Transcatheter Intramyocardial Septal Radiofrequency Ablation System in people with Hypertrophic Cardiomyopathy, Obstructive, run by SuZhou Sinus Medical Technologies Co.,Ltd at 2 sites in China.
Trial summary
This is a prospective, multicenter, randomized, parallel-controlled, superiority clinical trial designed to evaluate the efficacy and safety of a transcatheter intramyocardial septal radiofrequency ablation system for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Obstructive
- What is being tested?
- Transcatheter Intramyocardial Septal Radiofrequency Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jul 2025to 30 Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, regardless of sex
- Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)
- Presence of significant symptoms (e.g., dyspnea, chest pain, fatigue, palpitations, syncope)
- NYHA class II or higher with LVOTG ≥50 mmHg at rest or provoked (assessed by echocardiography)
- Septal thickness ≥15 mm
- Unsuitable for surgical myectomy or refusal of surgery
- Provided informed consent and agree to complete follow-up
Who cannot join
- Asymptomatic or non-obstructive HCM
- Septal thickness ≥30 mm
- Mitral valve anatomy not suitable for ablation as judged by investigator
- High risk of sudden cardiac death (SCD) requiring ICD implantation
- Complete right bundle branch block at screening
- Infective endocarditis, myocarditis, atrial myxoma, or intracardiac thrombus
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- Contraindication to transseptal access (e.g., septal patch)
- Mechanical valves or history of aortic valve replacement
- Severe heart failure with persistent symptoms and LVEF <40%
- Major cardiac events within 6 months (e.g., cardiac arrest, MI, heart failure hospitalization)
- Significant structural heart disease requiring surgery
- Prior septal reduction therapy or pacemaker implantation
- Constrictive pericarditis or significant congenital heart disease
- Bleeding disorders or contraindication to antithrombotic therapy
- Liver dysfunction (ALT/AST >3× ULN)
- Renal insufficiency (creatinine >2.0 mg/dL or on dialysis)
- Pregnant, breastfeeding, or planning pregnancy within 6 months post-op
- Life expectancy <12 months
- Participation in other investigational studies within 30 days or 5 half-lives
- Investigator determines poor compliance or unsuitability
- Contraindications to cardiac MRI (e.g., ICD, allergy to contrast, claustrophobia)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Capital Medical University Affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
- Recruiting
Sir Run Run Shaw hospital
Hangzhou, Zhejiang, 310016
About this study
Official title: A Prospective, Multicenter, Randomized, Parallel-Controlled Superiority Study Evaluating the Efficacy and Safety of a Transcatheter Intramyocardial Septal Radiofrequency Ablation System in Patients With Obstructive Hypertrophic Cardiomyopathy
This is a prospective, multicenter, randomized, parallel-controlled, superiority clinical trial designed to evaluate the efficacy and safety of a transcatheter intramyocardial septal radiofrequency ablation system for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM). Eligible participants will be randomized in a 2:1 ratio to receive either active ablation under intracardiac echocardiographic guidance or a sham procedure. All participants will continue to receive standard-of-care medical therapy during the study period. The primary endpoint is the treatment effectiveness rate at 6 months, defined as a ≥50% reduction in LVOT gradient from baseline or a resting LVOT gradient <30 mmHg.
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive
- Being tested
- Transcatheter 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.
Transcatheter Intramyocardial Septal Radiofrequency Ablation SystemDevice
The device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE).
| Study group | Role | What they receive |
|---|---|---|
| Septal RF Ablation Group | Experimental | Participants in this group will receive a transcatheter intramyocardial septal radiofrequency ablation under intracardiac echocardiography (ICE) guidance using the investigational device system. Standardized pharmacological therapy will be continued throughout the study period. Receives: Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System |
| Sham Procedure (No RF Ablation) | Sham comparator | Participants in this group will undergo a sham procedure under ICE guidance. The catheter will be inserted but no ablation will be performed. Participants will continue standardized pharmacological therapy throughout the study period. After completion of the 6-month follow-up, participants in this arm may voluntarily choose to receive the investigational treatment. Receives: Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effectiveness Rate at 6 Months
Defined as either (1) a ≥50% reduction in resting LVOT gradient from baseline, or (2) resting LVOT gradient <30 mmHg.
Measured: 6 months post-procedure
Secondary outcomes (6)
Change in Resting LVOT Gradient
Measured by echocardiography at baseline, 6 months, and 12 months
Measured: Baseline, 6 months, 12 months
Change in NYHA Functional Class
Proportion of patients with improvement of ≥1 NYHA class
Measured: Baseline, 6 months, 12 months
Change in 6-Minute Walk Distance
Distance walked in 6 minutes, compared to baseline
Measured: Baseline, 6 months, 12 months
Change in 12-Item Short Form Health Survey (SF-12) Score
The SF-12 Health Survey includes two components: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better health status.
Measured: Baseline, 6 months, 12 months
Device Success Rate
Defined as successful completion of RF ablation per protocol
Measured: Day of procedure
Incidence of Adverse Events
All adverse events related to device or procedure
Measured: Through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start20 Jul 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy, ObstructiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SuZhou Sinus Medical Technologies Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changshen Ma, Doctor, Principal investigator, Capital Medical University Affiliated Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006493
- Sponsor's protocol ID
- CRCT-001
- Acronym
- REFINE-HCM
- Status last verified
- Dec 2025
- First submitted
- 27 May 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) for this study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Parallel-Controlled Superiority Study Evaluating the Efficacy and Safety of a Transcatheter Intramyocardial Septal Radiofrequency Ablation System in Patients With Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07006493
- Acronym / sponsor ID
- REFINE-HCM / CRCT-001
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- SuZhou Sinus Medical Technologies Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Jun 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.
This is a prospective, multicenter, randomized, parallel-controlled, superiority clinical trial designed to evaluate the efficacy and safety of a transcatheter intramyocardial septal radiofrequency ablation system for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM). Eligible participants will be randomized in a 2:1 ratio to receive either active ablation under intracardiac echocardiographic guidance or a sham procedure. All participants will continue to receive standard-of-care medical therapy during the study period. The primary endpoint is the treatment effectiveness rate at 6 months, defined as a ≥50% reduction in LVOT gradient from baseline or a resting LVOT gradient <30 mmHg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septal RF Ablation Group | Experimental | Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation SystemParticipants in this group will receive a transcatheter intramyocardial septal radiofrequency ablation under intracardiac echocardiography (ICE) guidance using the investigational device system. Standardized pharmacological therapy will be continued throughout the study period. |
| Sham Procedure (No RF Ablation) | Sham comparator | Device: Transcatheter Intramyocardial Septal Radiofrequency Ablation SystemParticipants in this group will undergo a sham procedure under ICE guidance. The catheter will be inserted but no ablation will be performed. Participants will continue standardized pharmacological therapy throughout the study period. After completion of the 6-month follow-up, participants in this arm may voluntarily choose to receive the investigational treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years, regardless of sex
- Diagnosed with obstructive hypertrophic cardiomyopathy (oHCM)
- Presence of significant symptoms (e.g., dyspnea, chest pain, fatigue, palpitations, syncope)
- NYHA class II or higher with LVOTG ≥50 mmHg at rest or provoked (assessed by echocardiography)
- Septal thickness ≥15 mm
Key exclusion criteria (21 listed)
- Asymptomatic or non-obstructive HCM
- Septal thickness ≥30 mm
- Mitral valve anatomy not suitable for ablation as judged by investigator
- High risk of sudden cardiac death (SCD) requiring ICD implantation
- Complete right bundle branch block at screening
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 |
|---|---|---|
| Transcatheter Intramyocardial Septal Radiofrequency Ablation SystemThe device system includes a single-use RF ablation catheter, sheath, RF generator, and irrigation pump. Ablation is guided by intracardiac echocardiography (ICE). | Device | Septal RF Ablation Group, Sham Procedure (No RF Ablation) |
Primary outcome
Treatment Effectiveness Rate at 6 Months
Time frame: 6 months post-procedure
Defined as either (1) a ≥50% reduction in resting LVOT gradient from baseline, or (2) resting LVOT gradient <30 mmHg.
6 secondary outcomes
Change in Resting LVOT Gradient
Time frame: Baseline, 6 months, 12 months
Change in NYHA Functional Class
Time frame: Baseline, 6 months, 12 months
Change in 6-Minute Walk Distance
Time frame: Baseline, 6 months, 12 months
Change in 12-Item Short Form Health Survey (SF-12) Score
Time frame: Baseline, 6 months, 12 months
Device Success Rate
Time frame: Day of procedure
Incidence of Adverse Events
Time frame: Through 12 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 15 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) for this study.
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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.
Changshen Ma, Doctor principal investigator
Capital Medical University Affiliated Beijing Anzhen Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Intramyocardial Septal Radiofrequency Ablation System in people with Hypertrophic Cardiomyopathy, Obstructive, run by SuZhou Sinus Medical Technologies Co.,Ltd at 2 sites 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 7 inclusion and 21 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Yongxin Su (+86 18121015668, suyongxin@sinusmedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Effectiveness Rate at 6 Months (time frame: 6 months post-procedure). 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 15 Dec 2025.