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Impact of Amyloidosis on TAVI Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03984877
Acronym
AMY-TAVI
Enrollment
320
Registered
2019-06-13
Start date
2019-01-01
Completion date
2021-12-31
Last updated
2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis Cardiac, Valve Stenoses, Aortic

Keywords

TAVI, Aortic Stenosis, Cardiac amyloidosis

Brief 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.

Interventions

DIAGNOSTIC_TESTDiagnosis of amyloidosis

Scintigraphy and protein electrophoresis

Sponsors

Javier López Pais
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

* Aortic valve replacement with a percutaneous prosthesis due to severe aortic stenosis after evaluation by the Heart Team. * Ability to understand and sign informed consent. * They do not meet any of the

Exclusion criteria

.

Design outcomes

Primary

MeasureTime frameDescription
Mortality1 yearSurvival after TAVI of patients with amyloidosis

Secondary

MeasureTime frameDescription
Pacemaker requirements15 daysNumber of patients with amyloidosis who received pacemaker after TAVI.

Countries

Spain

Contacts

Primary ContactDiego Lopez Otero, M.D.
Diego.Lopez.Otero@sergas.es981 95 00 00
Backup ContactJavier López Pais, M.D. Ph.D.
javierlopezpais@gmail.com981 95 00 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026