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This is a prospective, single-center, single-arm clinical study. All patients were diagnosed with obstructive hypertrophic cardiomyopathy, and only subjects who met the instrument indications of this study were treated. After signing an informed consent form, subjects are enrolled and treated with the DragonFire Transcatheter Myocardial Ablation System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, and 12 months after the procedure.
This is a prospective, single-center, single-arm clinical study. All patients were diagnosed with obstructive hypertrophic cardiomyopathy, and only subjects who met the instrument indications of this study were treated. After signing an informed consent form, subjects are enrolled and treated with the DragonFire Transcatheter Myocardial Ablation System. The primary efficacy endpoint was the rate of major adverse events 30 days after surgery. The safety endpoints were the rate of immediate postoperative success and postoperative device success All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, and 12 months after the procedure.
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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 |
|---|---|---|
| Incidence of MAE | Major adverse Event (MAE) is defined as any instrument-related or surgery-related complication, including death, emergency surgery, severe pericardial tamponade requiring pericardiocentesis or surgery, bleeding, surgery-related stroke, pacemaker implantation, and mechanically assisted circulation | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedural success | The device arrived at the intended treatment site for ablation, and was successfully withdrawn after ablation | Immediately after procedure |
| Percentage of subjects with left ventricular outflow tract pressure (LVOTG) reduction of ≥50% or left ventricular outflow tract pressure (LVOTG) < 30mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang ZhenFei, Phd | The Second Xiangya Hospital, Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital, Central South University | Changsha | Hunan | 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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Percentage of subjects with left ventricular outflow tract pressure (LVOTG) reduction of ≥50% or LVOTG< 30mmHg after the procedure |
| 12 months |
| Incidence of device or device-related adverse events and device defects | 12 months |
| Quality of life improvement | Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire,a scale of 0-100 with higher scores indicating better health | 6 months, 12months |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |