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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 HLT Transcatheter Aortic Valve System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLT Transcatheter Aortic Valve System | Device | Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint: 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: Procedural Device Performance | The secondary performance endpoint is Device Success defined as:
|
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Inclusion Criteria:
70 years of age or older
Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec
Symptomatology due to aortic stenosis resulting in one of the following:
Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter
STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities.
Geographically available, willing to comply with follow up and able to provide written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Rodés-Cabau, MD | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Harindra Wijeysundera, MD | Sunnybrook Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Center | Toronto | Ontario | M4N 3M5 | Canada | ||
| Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31362540 | Result | Rodes-Cabau J, Williams MR, Wijeysundera HC, Kereiakes DJ, Paradis JM, Staniloae C, Saric M, Radhakrishnan S, Wilson RF, Kubo SH. Transcatheter Aortic Valve Replacement With the HLT Meridian Valve. Circ Cardiovasc Interv. 2019 Aug;12(8):e008053. doi: 10.1161/CIRCINTERVENTIONS.119.008053. Epub 2019 Jul 31. |
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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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| 1 day |
| Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Effective Orifice Area) | Aortic valve effective orifice area (EOA) will be evaluated with echocardiograms | 1 week, 1, 6, 12, 24, 36, 48 and 60 months |
| Secondary Performance Endpoint 2: Post-procedural Valve Performance (Severity of Aortic Valve Regurgitation) | Severity of aortic valve regurgitation (AR) will be evaluated with echocardiograms | 1 week, 1, 6, 12, 24, 36, 48 and 60 months |
| Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Gradient) | Aortic valve gradient will be evaluated with echocardiograms | 1 week, 1, 6, 12, 24, 36, 48 and 60 months |
| Secondary Safety Endpoint 3: Adverse Events | All adverse events will be assessed throughout the 5 year follow up period. | throughout the 5 year follow up period |
| Québec |
| Quebec |
| G1V 4G5 |
| Canada |
| D014694 |
| Ventricular Outflow Obstruction |