Impact of Amyloidosis on TAVI Patients

Amyloidosis Cardiac Clinical Trial

— AMY-TAVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984877
• Other study ID #: AMY-TAVI
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2019
• Source: Hospital Clinico Universitario de Santiago
• Contact: Diego Lopez Otero, M.D.
• Phone: 981 95 00 00
• Email: Diego.Lopez.Otero[@]sergas.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis Cardiac
• Aortic Valve Stenosis
• Constriction, Pathologic
• Valve Stenoses, Aortic

Intervention

Diagnostic Test:
• Diagnosis of amyloidosis
Scintigraphy and protein electrophoresis

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	Galicia

Sponsors (1)

Lead Sponsor	Collaborator
Javier López Pais

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Survival after TAVI of patients with amyloidosis	1 year
Secondary	Pacemaker requirements	Number of patients with amyloidosis who received pacemaker after TAVI.	15 days