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The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLT Transcatheter Aortic Valve System | Experimental | Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLT Transcatheter Aortic Valve System | Device | Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Performance Endpoint 1: Procedural Device Performance | The primary performance endpoint is the Device Success defined as:
| Post procedure (day of procedure) |
| Primary Safety Endpoint 2: Mortality at 30 days | The primary safety endpoint is all-cause mortality at 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Performance Endpoint 1: Post-procedural Valve Performance | The HLT Valve performance will be evaluated by the following parameters with echocardiograms obtained at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months:
| pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months |
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Inclusion Criteria:
Exclusion Criteria:
"*"At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility.
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| Name | Affiliation | Role |
|---|---|---|
| Axel Linke, MD | University of Leipzig - Herzzcntrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leipzig - Heart Center | Leipzig | 04289 | Germany |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Secondary Safety Endpoint 2: Adverse Events | All adverse events will be assessed throughout the 5 year follow up period | throughout the 5 year follow up period |
| D014694 |
| Ventricular Outflow Obstruction |