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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

Tracking Information
First Submitted Date January 22, 2019
First Posted Date June 13, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2019)
Mortality [ Time Frame: 1 year ]
Survival after TAVI of patients with amyloidosis
Original Primary Outcome Measures
 (submitted: June 11, 2019)
Mortality [ Time Frame: 1 year ]
Impact on TAVI patients survival of amyloidosis
Change History Complete list of historical versions of study NCT03984877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 11, 2019)
Pacemaker requirements [ Time Frame: 15 days ]
Number of patients with amyloidosis who received pacemaker after TAVI.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Amyloidosis on TAVI Patients
Official Title Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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).
Condition
  • Valve Stenoses, Aortic
  • Amyloidosis Cardiac
Intervention Diagnostic Test: Diagnosis of amyloidosis
Scintigraphy and protein electrophoresis
Study Groups/Cohorts
  • Amyloidosis
    TAVI patients with diagnosis of amyloidosis
    Intervention: Diagnostic Test: Diagnosis of amyloidosis
  • Non-Amyloidosis
    TAVI patients without diagnosis of amyloidosis
    Intervention: Diagnostic Test: Diagnosis of amyloidosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 11, 2019)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03984877
Other Study ID Numbers AMY-TAVI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Javier López Pais, Hospital Clinico Universitario de Santiago
Study Sponsor Javier López Pais
Collaborators Not Provided
Investigators
Study Chair: Jose Ramón Gonzalez Juantey, M.D. Ph.D. Complexo Hospitalario Universitario de Santiago de Compostela
PRS Account Hospital Clinico Universitario de Santiago
Verification Date June 2019