Impact of Amyloidosis on TAVI Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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

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Valve Stenoses, Aortic Amyloidosis Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Amyloidosis

TAVI patients with diagnosis of amyloidosis

Diagnosis of amyloidosis

Intervention Type DIAGNOSTIC_TEST

Scintigraphy and protein electrophoresis

Non-Amyloidosis

TAVI patients without diagnosis of amyloidosis

Diagnosis of amyloidosis

Intervention Type DIAGNOSTIC_TEST

Scintigraphy and protein electrophoresis

Interventions

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Diagnosis of amyloidosis

Scintigraphy and protein electrophoresis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No