Survival, ProsthesisSPAVALVENCT03595423
SPAnish Aortic VALVE Multicentric Study
An observational study of Survival, Prosthesis and Prosthesis Durability, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Survival, Prosthesis, Prosthesis Durability, Valve Heart Disease
- What is being tested?
- Surgical AVR with bioprosthetic or mechanical prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2018to 30 Jun 2019
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive, with bioprosthesis or mechanical prosthesis implantation
Who may be able to join
- Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive
Who cannot join
- Not reported Residency change (unreachable)
- Need of concomitant surgery
- Reoperations
- Infective endocarditis
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen de La Victoria
Málaga
EMILIANO RODRIGUEZ-CAULO (Coordinator), MD, PhD, +34951032054, erodriguezcaulo@hotmail.com
+34951032054, erodriguezcaulo@hotmail.com
About this study
Official title: Retrospective Multicentric Study Spanish SPALVALVE: Follow-up to 15 Years of Patients Between 50-65 Years Undergoing Isolated Aortic Valve Replacement. Biological or Mechanical Prostheses
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B.
Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era. The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 30 Cardiovascular Surgery Centers in Spain
Read the detailed description
Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (early 30-day death, stroke, any prosthesis reoperation, and major bleeding), in patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) due to severe aortic stenosis . Secondary objectives were to analyze the evolution of transprosthetic gradients by echocardiography,, and degree of significant structural degeneration in bioprostheses.
Material and Method: A retrospective analytical study of patients aged 50-65 years who underwent AVR surgery for stenosis between 2000-2015 in 30 centers with a Cardiovascular Surgery Dept. in SPAIN as an inclusion criterion. As exclusion criteria, autonomic change of residence, need for concomitant surgery, previous cardiac interventions and infective endocarditis.
Survival analysis and clinical data records will be performed through the Public Health Care computed medical records , and direct telephone contact with family and / or relatives, in case of doubts. A crude analysis of the data and a posterior analysis by propensity score matching with SPSS or R software will be carried out using a 1: 1 or 2:1 "nearest neighbour" matching protocol based on the Number of total bioprosthesis. A total sample of more than 5000 cases is expected, of which about 1000 would be bioprostheses that would serve as a basis for the pairing. According to previous data(ANDALVALVE STUDY), to find a 4.8% difference in the primary endpoint, two groups of 1025 patients are required for a p = 0.05 and 80% for a bilateral contrast of two independent proportions. Subanalysis will be performed by subgroups of age (50-55 vs. 55-65 years) and another according to the mark of the 2 prostheses of each type most implanted. All statistical analyzes will be two-tailed with an alpha error of 0.05 to consider statistically significant data, and will be reviewed by IBIMA or Private biostatistics. Competing risks analysis will be performed to calculate the cumulative incidence of stroke, reoperation and major bleeding for each prosthesis type.
Conclusions: A positive result (similar survival in group B, with lower complications) could change the current indications of AVR in our environment, allowing the age of indication for bioprostheses in European guidelines to be reduced below 60 years
- Being tested
- Surgical AVR with bioprosthetic or mechanical prosthesis
- Keywords
- long-term survival, bioprosthesis
- Medical subject headings
- Prosthesis Failure, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical AVR with bioprosthetic or mechanical prosthesisProcedure or surgery
Surgical AVR with bioprosthetic or mechanical prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Bioprosthesis | All patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive. Receives: Procedure: Surgical AVR with bioprosthetic or mechanical prosthesis | |
| Mechanical prosthesis | All patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive. Receives: Procedure: Surgical AVR with bioprosthetic or mechanical prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants alive
Survival since surgery
Measured: From date of surgery until the date of death from any cause, assessed up to 18 years
Late postoperative combined endpoint of 4 Major Adverse Cardiovascular Events (MACE) complications
Early 30-day Mortality, major bleeding, stroke and need of any prosthesis reoperation
Measured: From date of surgery until the date of first documented MACE (see description) or date of death from any cause, whichever came first, assessed up to 18 years
Secondary outcomes (3)
Cumulative incidence of stroke at 15 years between groups
stroke cumulative incidence over time (competing risk analysis)
Measured: From date of surgery until the date of first documented stroke or date of death from any cause, whichever came first, assessed up to 18 years
Cumulative incidence of prosthesis reoperation at 15 years between groups
reoperation cumulative incidence over time (competing risk analysis)
Measured: From date of surgery until the date of first documented reoperation or date of death from any cause, whichever came first, assessed up to 18 years
Cumulative incidence of major bleeding at 15 years between groups
major bleeding cumulative incidence over time (competing risk analysis)
Measured: From date of surgery until the date of first documented major bleeding or date of death from any cause, whichever came first, assessed up to 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start10 Jul 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival, ProsthesisStudies 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595423
- Sponsor's protocol ID
- SPAVALVE
- Acronym
- SPAVALVE
- Status last verified
- Jul 2018
- First submitted
- 11 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicentric Study Spanish SPALVALVE: Follow-up to 15 Years of Patients Between 50-65 Years Undergoing Isolated Aortic Valve Replacement. Biological or Mechanical Prostheses
- ClinicalTrials.gov ID
- NCT03595423
- Acronym / sponsor ID
- SPAVALVE / SPAVALVE
- Keywords
- long-term survival, bioprosthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 23 Jul 2018 (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.
Currently there is an increase in the use of bioprosthesis worldwide (> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B.
Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era. The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 30 Cardiovascular Surgery Centers in Spain
Detailed description
Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (early 30-day death, stroke, any prosthesis reoperation, and major bleeding), in patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) due to severe aortic stenosis . Secondary objectives were to analyze the evolution of transprosthetic gradients by echocardiography,, and degree of significant structural degeneration in bioprostheses.
Material and Method: A retrospective analytical study of patients aged 50-65 years who underwent AVR surgery for stenosis between 2000-2015 in 30 centers with a Cardiovascular Surgery Dept. in SPAIN as an inclusion criterion. As exclusion criteria, autonomic change of residence, need for concomitant surgery, previous cardiac interventions and infective endocarditis.
Survival analysis and clinical data records will be performed through the Public Health Care computed medical records , and direct telephone contact with family and / or relatives, in case of doubts. A crude analysis of the data and a posterior analysis by propensity score matching with SPSS or R software will be carried out using a 1: 1 or 2:1 "nearest neighbour" matching protocol based on the Number of total bioprosthesis. A total sample of more than 5000 cases is expected, of which about 1000 would be bioprostheses that would serve as a basis for the pairing. According to previous data(ANDALVALVE STUDY), to find a 4.8% difference in the primary endpoint, two groups of 1025 patients are required for a p = 0.05 and 80% for a bilateral contrast of two independent proportions. Subanalysis will be performed by subgroups of age (50-55 vs. 55-65 years) and another according to the mark of the 2 prostheses of each type most implanted. All statistical analyzes will be two-tailed with an alpha error of 0.05 to consider statistically significant data, and will be reviewed by IBIMA or Private biostatistics. Competing risks analysis will be performed to calculate the cumulative incidence of stroke, reoperation and major bleeding for each prosthesis type.
Conclusions: A positive result (similar survival in group B, with lower complications) could change the current indications of AVR in our environment, allowing the age of indication for bioprostheses in European guidelines to be reduced below 60 years
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioprosthesis | – | Procedure: Surgical AVR with bioprosthetic or mechanical prosthesisAll patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive. |
| Mechanical prosthesis | – | Procedure: Surgical AVR with bioprosthetic or mechanical prosthesisAll patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive, with bioprosthesis or mechanical prosthesis implantation
Key inclusion criteria (1 listed)
- Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive
Key exclusion criteria (4 listed)
- Not reported Residency change (unreachable)
- Need of concomitant surgery
- Reoperations
- Infective endocarditis
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 |
|---|---|---|
| Surgical AVR with bioprosthetic or mechanical prosthesisSurgical AVR with bioprosthetic or mechanical prosthesis | Procedure or surgery | Bioprosthesis, Mechanical prosthesis |
Primary outcome
Number of participants alive
Time frame: From date of surgery until the date of death from any cause, assessed up to 18 years
Survival since surgery
Late postoperative combined endpoint of 4 Major Adverse Cardiovascular Events (MACE) complications
Time frame: From date of surgery until the date of first documented MACE (see description) or date of death from any cause, whichever came first, assessed up to 18 years
Early 30-day Mortality, major bleeding, stroke and need of any prosthesis reoperation
3 secondary outcomes
Cumulative incidence of stroke at 15 years between groups
Time frame: From date of surgery until the date of first documented stroke or date of death from any cause, whichever came first, assessed up to 18 years
Cumulative incidence of prosthesis reoperation at 15 years between groups
Time frame: From date of surgery until the date of first documented reoperation or date of death from any cause, whichever came first, assessed up to 18 years
Cumulative incidence of major bleeding at 15 years between groups
Time frame: From date of surgery until the date of first documented major bleeding or date of death from any cause, whichever came first, assessed up to 18 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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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.
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 Survival, Prosthesis and Prosthesis Durability, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 1 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 23 Jul 2018. 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 EMILIANO A RODRIGUEZ CAULO, MD, PhD,FECTS (+34951032054, erodriguezcaulo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants alive (time frame: From date of surgery until the date of death from any cause, assessed up to 18 years). The study lists 2 primary outcomes in all. 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 23 Jul 2018.