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Status unknownNCT03984877AMY-TAVIUpdated Jun 14, 2019

Impact of Amyloidosis on TAVI Patients

An observational study in Valve Stenoses, Aortic and Amyloidosis Cardiac, sponsored by Javier López Pais. Status unknown at 1 site in Spain. Open to participants aged 60 Years to 110 Years. Per ClinicalTrials.gov, last updated 2019-06-14.

Sponsored by Javier López Pais · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Ages
60 Years to 110 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Valve Stenoses, Aortic
  • Amyloidosis Cardiac

Keywords

  • TAVI
  • Aortic Stenosis
  • Cardiac amyloidosis
03

In context

Aortic Valve Stenosis

1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.

This study's planned enrollment of 320 is above the median of 200 across 431 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

This is the only study on the registry with Javier López Pais as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 110 Years
Sexes eligible
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testDiagnosis of amyloidosis

    Scintigraphy and protein electrophoresis

06

What researchers measure

Primary outcomes

  1. Mortality

    Survival after TAVI of patients with amyloidosis

    Time frame: 1 year

Secondary outcomes

  1. Pacemaker requirements

    Number of patients with amyloidosis who received pacemaker after TAVI.

    Time frame: 15 days

07

Study locations

1 of 1 sites recruiting
  • Hospital Clínico Universitario de Santiago de Compostela
    Santiago de Compostela, Galicia 15703, Spain
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 29, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Dec 2021, 35 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 125. This study's planned 35 months is below that.

Counting every sponsor, half of 241 studies reached it within 44 months; a quarter within 23 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2019
First posted
Jun 13, 2019
StartActual
Jan 1, 2019
Primary completionEst.
Dec 31, 2021
CompletionEst.
Dec 31, 2021
Last update
Jun 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03984877
Lead sponsor
Javier López Pais
Responsible party
Javier López Pais (Sponsor-Investigator, Hospital Clinico Universitario de Santiago) — Sponsor-investigator
First posted
Jun 13, 2019
Start date
Jan 1, 2019
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jun 14, 2019

Study contacts

Diego Lopez Otero, M.D.
Contact
Diego.Lopez.Otero@sergas.es
981 95 00 00
Javier López Pais, M.D. Ph.D.
Contact
javierlopezpais@gmail.com
981 95 00 00
Jose Ramón Gonzalez Juantey, M.D. Ph.D.
study chair · Complexo Hospitalario Universitario de Santiago de Compostela

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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