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New treatment option for Hypertrophic Cardiomyopathy, Obstructive
Official title REFINE-HCM: Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy
ClinicalTrials.gov ID: NCT07006493
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.