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To analyze the prevalence and impact on the prognosis of amyloidosis due to transthyretin in patients with severe aortic stenosis who undergo percutaneous aortic valve implantation.
Type and design of the study: Multicentric, prospective cohort, observational.
Number and characteristics of the patients: 321 patients to whom TAVI has been implanted due to severe degenerative AS.
Duration of the study
Inclusion: 1 year
Follow up: 2 years
Data analysis: 6 months
Total: 3 years and 6 months
Events
Countries and participating centers: Various Spanish and international centers will be invited to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amyloidosis | TAVI patients with diagnosis of amyloidosis |
| |
| Non-Amyloidosis | TAVI patients without diagnosis of amyloidosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnosis of amyloidosis | Diagnostic Test | Scintigraphy and protein electrophoresis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Survival after TAVI of patients with amyloidosis | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pacemaker requirements | Number of patients with amyloidosis who received pacemaker after TAVI. | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include patients of legal age, recruited in the hospitalization area or from outpatient clinics, who meet the following requirements: diagnosis of severe aortic stenosis by conventional echocardiographic criteria (maximum speed> 4m / s, medium transvalvular gradient> 40mmHg, area <1cm2).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diego Lopez Otero, M.D. | Contact | 981 95 00 00 | Diego.Lopez.Otero@sergas.es | |
| Javier López Pais, M.D. Ph.D. | Contact | 981 95 00 00 | javierlopezpais@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jose Ramón Gonzalez Juantey, M.D. Ph.D. | Complexo Hospitalario Universitario de Santiago de Compostela | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago de Compostela | Recruiting | Santiago de Compostela | Galicia | 15703 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2018 | Jun 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D014694 |
| Ventricular Outflow Obstruction |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |