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
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.