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This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The treament of DragonFire Transcatheter myocardial ablation system | Experimental | If drug therapy does not work or drug side effects are not tolerated, transaortic interventional surgery can be evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DragonFire Transcatheter Myocardial Radiofrequency Ablation System | Device | The patients with hypertrophic obstructive cardiomyopathy were treated with a transcatheter myocardial radiofrequency ablation system and its guiding system under the guidance of echocardiography |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of freedom from major adverse events at 30 days postoperatively | Definition of major adverse events: All-cause mortality within 30 days postoperatively, cardiovascular events requiring emergency intervention, malignant arrhythmias, new indication for permanent pacemaker implantation (non-reversible second-degree type II, high-degree, and third-degree atrioventricular block), left bundle branch block, right bundle branch block. | 30 days |
| The success rate of treatment at 6 months postoperatively | Definition of treatment success: Freedom from cardiac death at 6 months postoperatively, freedom from secondary re-intervention due to insufficient reduction in LVOTG, peak left ventricular outflow tract gradient (LVOTG) <30mmHg (at rest) or ≥50% decrease compared to baseline peak LVOTG (at rest or with provocation). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kangmu Ma, Phd | Contact | +8613341773508 | makangmu@valgenmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaling Han, Phd | Northern Theater Command General Hospital of the Chinese People's Liberation Army | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Theater Command General Hospital of the Chinese People's Liberation Army | Shenyang | China |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |