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Impact of Amyloidosis on TAVI Patients (AMY-TAVI)

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ClinicalTrials.gov Identifier: NCT03984877
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Javier López Pais, Hospital Clinico Universitario de Santiago

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.

Condition or disease Intervention/treatment
Valve Stenoses, Aortic Amyloidosis Cardiac Diagnostic Test: Diagnosis of amyloidosis

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
Amyloidosis
TAVI patients with diagnosis of amyloidosis
Diagnostic Test: Diagnosis of amyloidosis
Scintigraphy and protein electrophoresis

Non-Amyloidosis
TAVI patients without diagnosis of amyloidosis
Diagnostic Test: Diagnosis of amyloidosis
Scintigraphy and protein electrophoresis




Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
    Survival after TAVI of patients with amyloidosis


Secondary Outcome Measures :
  1. Pacemaker requirements [ Time Frame: 15 days ]
    Number of patients with amyloidosis who received pacemaker after TAVI.



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Ages Eligible for Study:   60 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984877


Contacts
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Contact: Diego Lopez Otero, M.D. 981 95 00 00 Diego.Lopez.Otero@sergas.es
Contact: Javier López Pais, M.D. Ph.D. 981 95 00 00 javierlopezpais@gmail.com

Locations
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Spain
Hospital Clínico Universitario de Santiago de Compostela Recruiting
Santiago de Compostela, Galicia, Spain, 15703
Contact: Javier López Pais, M.D.    981 95 00 00    javierlopezpais@gmail.com   
Contact: Diego López Otero, M.D. Ph.D.    981 95 00 00    Diego.Lopez.Otero@sergas.es   
Sponsors and Collaborators
Javier López Pais
Investigators
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Study Chair: Jose Ramón Gonzalez Juantey, M.D. Ph.D. Complexo Hospitalario Universitario de Santiago de Compostela
  Study Documents (Full-Text)

Documents provided by Javier López Pais, Hospital Clinico Universitario de Santiago:

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Responsible Party: Javier López Pais, Sponsor-Investigator, Hospital Clinico Universitario de Santiago
ClinicalTrials.gov Identifier: NCT03984877     History of Changes
Other Study ID Numbers: AMY-TAVI
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier López Pais, Hospital Clinico Universitario de Santiago:
TAVI
Aortic Stenosis
Cardiac amyloidosis

Additional relevant MeSH terms:
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Constriction, Pathologic
Amyloidosis
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Proteostasis Deficiencies
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction