Impact of Amyloidosis on TAVI Patients

Last updated: June 12, 2019
Sponsor: Javier López Pais
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Treatment

N/A

Clinical Study ID

NCT03984877
AMY-TAVI
  • Ages 60-110
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aortic valve replacement with a percutaneous prosthesis due to severe aortic stenosisafter evaluation by the Heart Team.

  • Ability to understand and sign informed consent.

  • They do not meet any of the exclusion criteria.

Exclusion

Exclusion Criteria:

  • Death as a complication of the procedure during hospitalization.

  • Associated mitral valve disease requiring intervention

  • TAVI valve-in-valve implant.

  • Does not sign informed consent.

Study Design

Total Participants: 320
Study Start date:
January 01, 2019
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, Galicia 15703
    Spain

    Active - Recruiting

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