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The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Patients who undergo TAVI for symptomatic severe stenosed aortic heart valves | |||
| Cohort 2: | patients undergoing a VIV procedure in failing surgical bioprostheses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | up to five years | |
| Technical success of implantation | Technical success of implantation, as defined by:
|
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Inclusion Criteria:
Exclusion Criteria:
General:
Patients with native aortic valve disease:
Patients with degenerated surgical bioprosthetic aortic valves:
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Symptomatic patients with elevated surgical risk and candidate for TAVI with severe calcified and stenotic aortic valves or failing surgical bioprosthetic aortic valves.
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Schäfer, MD | Herz-und Gefäßzentrum Bad Bevensen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | 90220 | Finland | |||
| Herz- und Gefäßzentrum Bad Bevensen |
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| day of procedure |
| Assesment of NYHA classification | 30 days, 12 month, 24 month, 36 month, 48 month, 60 month |
| Safety profile according to VARC II | Early Safety
Time-related valve safety
| 30 days |
| In-hospital mortality | date of procedure till date of estimated discharge, assessed up to two weeks |
| Quality of life (EQ5D 5L) | 30 days, 12 month, 24 month, 36 month, 48 month, 60 month |
| New pacemaker implantation | up to five years |
| assessment of mean aortic gradient post-implantation | up to five years |
| Bad Bevensen |
| 29549 |
| Germany |
| Schuechtermann-klinik | Bad Rothenfelde | Germany |
| Kath. Marienkrankenhaus | Hamburg | 22087 | Germany |
| MH Hannover | Hanover | 30625 | Germany |
| SLK-Kliniken Heilbronn | Heilbronn | 74078 | Germany |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Clinica Mediterranea Neapel | Naples | Italy |
| Heartcentre Catharina Hospital Eindhoven | Eindhoven | 5623 EJ | Netherlands |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | 36213 | Spain |
| Morriston Hospital | Swansea | United Kingdom |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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