Impact of Amyloidosis on TAVI Patients

NCT03984877 | Unknown

• 1 other identifier: AMY-TAVI
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Valve Stenoses, Aortic; Amyloidosis Cardiac

Keywords

TAVI; Aortic Stenosis; Cardiac amyloidosis

Outcome Measures

Primary Outcomes (1)

• Mortality

  Survival after TAVI of patients with amyloidosis

  1 year

Secondary Outcomes (1)

• Pacemaker requirements

  15 days

Study Arms (2)

Amyloidosis

TAVI patients with diagnosis of amyloidosis

Diagnostic Test: Diagnosis of amyloidosis

Non-Amyloidosis

TAVI patients without diagnosis of amyloidosis

Diagnostic Test: Diagnosis of amyloidosis

Interventions

Diagnosis of amyloidosis DIAGNOSTIC_TEST

Scintigraphy and protein electrophoresis

Amyloidosis; Non-Amyloidosis

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Javier López Pais: lead

Study Sites (1)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, 15703, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Jose Ramón Gonzalez Juantey, M.D. Ph.D.

  Complexo Hospitalario Universitario de Santiago de Compostela

  STUDY CHAIR

Central Study Contacts

Diego Lopez Otero, M.D.

CONTACT

981 95 00 00; Diego.Lopez.Otero@sergas.es

Javier López Pais, M.D. Ph.D.

CONTACT

981 95 00 00; javierlopezpais@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: June 13, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

ES (1)