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出境医 / 临床实验 / Impact of Amyloidosis on TAVI Patients (AMY-TAVI)
Impact of Amyloidosis on TAVI Patients (AMY-TAVI)
Study Description
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.
Study Design
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- Mortality [ Time Frame: 1 year ]Survival after TAVI of patients with amyloidosis
Secondary Outcome Measures :
- Pacemaker requirements [ Time Frame: 15 days ]Number of patients with amyloidosis who received pacemaker after TAVI.
Eligibility Criteria
| 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.
Contacts and Locations
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 |
Locations
| 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
| Study Chair: | Jose Ramón Gonzalez Juantey, M.D. Ph.D. | Complexo Hospitalario Universitario de Santiago de Compostela |
| 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 |
Mortality [ Time Frame: 1 year ] Survival after TAVI of patients with amyloidosis
|
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| Original Primary Outcome Measures |
Mortality [ Time Frame: 1 year ] Impact on TAVI patients survival of amyloidosis
|
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| Change History | |||||||||
| Current Secondary Outcome Measures |
Pacemaker requirements [ Time Frame: 15 days ] Number of patients with amyloidosis who received pacemaker after TAVI.
|
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| 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
Inclusion: 1 year Follow up: 2 years Data analysis: 6 months Total: 3 years and 6 months Events
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 |
|
||||||||
| Intervention | Diagnostic Test: Diagnosis of amyloidosis
Scintigraphy and protein electrophoresis
|
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| Study Groups/Cohorts |
|
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| 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 |
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:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 60 Years to 110 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
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| 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 |
|
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| IPD Sharing Statement |
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| Responsible Party | Javier López Pais, Hospital Clinico Universitario de Santiago | ||||||||
| Study Sponsor | Javier López Pais | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
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| PRS Account | Hospital Clinico Universitario de Santiago | ||||||||
| Verification Date | June 2019 | ||||||||
