Impact of Amyloidosis on TAVI Patients

• Conditions: Amyloidosis Cardiac; Valve Stenoses, Aortic
• Interventions: Diagnostic Test: Diagnosis of amyloidosis

• Registration Number: NCT03984877
• Lead Sponsor: Javier López Pais

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-22
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-11
• Last Update Submitted: 2019-06-12
• Study First Posted: 2019-06-13
• Last Update Posted: 2019-06-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Amyloidosis	Diagnosis of amyloidosis	TAVI patients without diagnosis of amyloidosis
Amyloidosis	Diagnosis of amyloidosis	TAVI patients with diagnosis of amyloidosis

Primary Outcome Measures

Name	Time	Method
Mortality	1 year	Survival after TAVI of patients with amyloidosis

Secondary Outcome Measures

Name	Time	Method
Pacemaker requirements	15 days	Number of patients with amyloidosis who received pacemaker after TAVI.

Trial Locations

Locations (1)

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, Galicia, Spain