Impact of Amyloidosis on TAVI Patients (AMY-TAVI)

Javier López Pais

Status: Unknown

Conditions: Amyloidosis Cardiac; Valve Stenoses, Aortic

Treatments: Diagnostic Test: Diagnosis of amyloidosis

Study type: Observational

Funder types: Other

Identifiers

NCT03984877

AMY-TAVI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 60 to 110 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

320 participants in 2 patient groups

Amyloidosis

Description:

TAVI patients with diagnosis of amyloidosis

Treatment:

Diagnostic Test: Diagnosis of amyloidosis

Non-Amyloidosis

Description:

TAVI patients without diagnosis of amyloidosis

Treatment:

Diagnostic Test: Diagnosis of amyloidosis