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| Name | Class |
|---|---|
| Meril Life Sciences Pvt. Ltd. | INDUSTRY |
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A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myval THV series | Device | Transcatheter Aortic Valve Implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Myval valve and TAVI procedure | Composite of:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Performance of Myval valve and TAVI procedure |
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic severe native aortic valve stenosis who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Domingues | Contact | +351217970685 | ana.domingues@spc.pt | |
| Joana D Silva, MD | Contact | +351217970685 | joanadelgadosilva@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Campante Teles, Prof. Dr. | Unidade Local de Saúde de Lisboa Ocidental, E.P.E. - Hospital de Santa Cruz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz | Recruiting | Carnaxide | 2790-134 | Portugal |
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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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| 30 days and 12 Months |
| Unidade Local de Saúde de Coimbra | Recruiting | Coimbra | 3004-561 | Portugal |
|
| Unidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo | Recruiting | Evora | 7000-811 | Portugal |
|
| Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta | Not yet recruiting | Lisbon | 1169-024 | Portugal |
|
| Unidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria | Recruiting | Lisbon | 1649-035 | Portugal |
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| Unidade Local de São João E.P.E. | Not yet recruiting | Porto | 4200-319 | Portugal |
|
| D014694 |
| Ventricular Outflow Obstruction |