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| Name | Class |
|---|---|
| Medstar Health Research Institute | OTHER |
| European Cardiovascular Research Center | NETWORK |
| University of British Columbia | OTHER |
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The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR | Experimental | with CENTERA self-expanding valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards CENTERA Self-Expanding Transcatheter Heart Valve | Device | The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR). |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality rate | NAP | 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| device success | Device success is defined as a composite of the following events: Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment). It is measured in % (favorable measures/total measures). | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Windecker, MD | Inselspital Bern (Switzerland) | Principal Investigator |
| Prof. Mohr, MD | Leipzig, Rhön Herzentrum (Germany) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Universitaet Bonn | Bonn | 53127 | Germany | |||
| Asklepios Klinik St Georg Hamburg |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| device success | Device success is defined as a composite of the following events: Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment). It is measured in % (favorable measures/total measures). | 1 year |
| Hamburg |
| 20099 |
| Germany |
| Heart Center Leipzig | Leipzig | 042 89 | Germany |
| Inselspital Bern | Bern | 3010 | Switzerland |