NCT03984877

Impact of Amyloidosis on TAVI Patients

Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 320 (estimated)
• Sponsor: Javier López Pais · Academic / Other
• Sex: All
• Age: 60 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Valve Stenoses, Aortic
• Amyloidosis Cardiac

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnosis of amyloidosis	Scintigraphy and protein electrophoresis

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-06-13
• Last updated: 2019-06-14

Locations

1 site across 1 country: Spain