Valve Stenoses, AorticAMY-TAVINCT03984877
Impact of Amyloidosis on TAVI Patients
An observational study of Valve Stenoses, Aortic and Amyloidosis Cardiac, run by Javier López Pais at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Valve Stenoses, Aortic, Amyloidosis Cardiac
- What is being tested?
- Diagnosis of amyloidosis
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 31 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, 15703
Javier López Pais, M.D., 981 95 00 00, javierlopezpais@gmail.com
Diego López Otero, M.D. Ph.D., 981 95 00 00, Diego.Lopez.Otero@sergas.es
About this study
Official title: Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic
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.
- Conditions
- Valve Stenoses, Aortic, Amyloidosis Cardiac
- Being tested
- Diagnosis of amyloidosis
- Keywords
- TAVI, Aortic Stenosis, Cardiac amyloidosis
- Medical subject headings
- Aortic Valve Stenosis, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of amyloidosisDiagnostic test
Scintigraphy and protein electrophoresis
| Study group | Role | What they receive |
|---|---|---|
| Amyloidosis | TAVI patients with diagnosis of amyloidosis Receives: Diagnostic Test: Diagnosis of amyloidosis | |
| Non-Amyloidosis | TAVI patients without diagnosis of amyloidosis Receives: Diagnostic Test: Diagnosis of amyloidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Survival after TAVI of patients with amyloidosis
Measured: 1 year
Secondary outcomes (1)
Pacemaker requirements
Number of patients with amyloidosis who received pacemaker after TAVI.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Stenoses, AorticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Javier López Pais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javier López Pais, Hospital Clinico Universitario de Santiago
- Investigators
- Jose Ramón Gonzalez Juantey, M.D. Ph.D., Study chair, Complexo Hospitalario Universitario de Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984877
- Sponsor's protocol ID
- AMY-TAVI
- Acronym
- AMY-TAVI
- Status last verified
- Jun 2019
- First submitted
- 22 Jan 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiac Amyloidosis on Patients With Severe Aortic Stenosis Who Undergo Transcatheter Aortic
- ClinicalTrials.gov ID
- NCT03984877
- Acronym / sponsor ID
- AMY-TAVI / AMY-TAVI
- Conditions
- Valve Stenoses, Aortic, Amyloidosis Cardiac
- Keywords
- TAVI, Aortic Stenosis, Cardiac amyloidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Javier López PaisUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amyloidosis | – | Diagnostic Test: Diagnosis of amyloidosisTAVI patients with diagnosis of amyloidosis |
| Non-Amyloidosis | – | Diagnostic Test: Diagnosis of amyloidosisTAVI patients without diagnosis of amyloidosis |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of amyloidosisScintigraphy and protein electrophoresis | Diagnostic test | Amyloidosis, Non-Amyloidosis |
Primary outcome
Mortality
Time frame: 1 year
Survival after TAVI of patients with amyloidosis
1 secondary outcome
Pacemaker requirements
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Ramón Gonzalez Juantey, M.D. Ph.D. study chair
Complexo Hospitalario Universitario de Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valve Stenoses, Aortic and Amyloidosis Cardiac, run by Javier López Pais at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Lopez Otero, M.D. (981 95 00 00, Diego.Lopez.Otero@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.