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Clinical Trial Summary

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.


Clinical Trial Description

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

- Recruitment period: All consecutive patients undergoing a non-invasive diagnostic study of amyloidosis (scintigraphy with technetium pyrophosphate99 and blood protein electrophoresis) will be recruited before discharge, in centers with proven experience, will accept non-invasive diagnosis with resonance) and have an implanted percutaneous aortic prosthesis for severe aortic stenosis.

- Follow-up period: clinical and echocardiographic follow-up will be carried out before discharge, in consultation at three, six, twelve and twenty-four months.

Inclusion: 1 year

Follow up: 2 years

Data analysis: 6 months

Total: 3 years and 6 months

Events

- Main event: cardiovascular events (cardiovascular death, stroke, infarction)

- Secondary events: death from any cause, readmission due to heart failure, pacemaker implantation, functional class evaluation

Countries and participating centers: Various Spanish and international centers will be invited to participate. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03984877
Study type Observational [Patient Registry]
Source Hospital Clinico Universitario de Santiago
Contact Diego Lopez Otero, M.D.
Phone 981 95 00 00
Email Diego.Lopez.Otero@sergas.es
Status Recruiting
Phase
Start date January 1, 2019
Completion date December 31, 2021

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