Clinical trial NCT03984877: Impact of Amyloidosis on TAVI Patients
Official title: Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valve Stenoses, Aortic
Amyloidosis Cardiac
Keywords: TAVI
Aortic Stenosis
Cardiac amyloidosis
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 320
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients of legal age, recruited in the hospitalization area or from outpatient clinics, who meet the following requirements: diagnosis of severe aortic stenosis by conventional echocardiographic criteria (maximum speed\> 4m / s, medium transvalvular gradient\> 40mmHg, area \<1cm2).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Pacemaker requirements
timeFrame: 15 days
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: Galicia
Study officials:
affiliation: Complexo Hospitalario Universitario de Santiago de Compostela
name: Jose Ramón Gonzalez Juantey, M.D. Ph.D.
role: STUDY_CHAIR
References: