New heart procedure aims to ease chest pain and shortness of breath
NCT ID NCT07006493
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new procedure that uses radiofrequency energy to reduce thickened heart muscle in people with obstructive hypertrophic cardiomyopathy. About 124 adults with symptoms like chest pain or shortness of breath will be randomly assigned to receive the active procedure or a sham procedure. The goal is to see if the treatment can safely improve blood flow from the heart and reduce symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Capital Medical University Affiliated Beijing Anzhen Hospital
RECRUITINGBeijing, Beijing Municipality, 100029, China
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Sir Run Run Shaw hospital
RECRUITINGHangzhou, Zhejiang, 310016, China
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