Transcatheter Aortic Valve ReplacementBIO TAVINCT02812953
Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
An observational study of Transcatheter Aortic Valve Replacement, run by Action, France at 1 site in France.
Trial summary
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Dec 2022
- How long will I take part?
- 12 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing TAVR
Who may be able to join
- patient undergoing TAVR intervention
- agreement given
Who cannot join
- severe thrombopenia ( <40.10^9/L)
Trial locations and contacts
1 site in 1 country.
About this study
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses
Read the detailed description
There are two major objectives:
- To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes
- To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).
- Conditions
- Transcatheter Aortic Valve Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
stroke/transient ischemic attack; acute coronary syndrome; hospitalization for cardiac insufficiency, cardiovascular or unexplained deaths will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician
Measured: 12 months
Bleeding
Serious bleeding event (BLEED II or more) will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician
Measured: 12 months
Secondary outcomes (1)
mean pressure transprosthetic gradient
value of the mean pressure transprosthetic gradient after TAVR procedure will be assessed by TTE (transthoracic echography) or TOE (transesophageal echography)
Measured: within ten days after valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies 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
- 600 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Action, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812953
- Sponsor's protocol ID
- 2015-A01832-47
- Acronym
- BIO TAVI
- Status last verified
- Jan 2019
- First submitted
- 30 May 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
- ClinicalTrials.gov ID
- NCT02812953
- Acronym / sponsor ID
- BIO TAVI / 2015-A01832-47
- Conditions
- Transcatheter Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Action, FranceUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Jun 2016 (estimated)
- 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.
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses
Detailed description
There are two major objectives:
- To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes
- To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing TAVR
Key inclusion criteria (2 listed)
- patient undergoing TAVR intervention
- agreement given
Key exclusion criteria (1 listed)
- severe thrombopenia ( <40.10^9/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiac Events
Time frame: 12 months
stroke/transient ischemic attack; acute coronary syndrome; hospitalization for cardiac insufficiency, cardiovascular or unexplained deaths will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician
Bleeding
Time frame: 12 months
Serious bleeding event (BLEED II or more) will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician
1 secondary outcome
mean pressure transprosthetic gradient
Time frame: within ten days after valve replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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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 Transcatheter Aortic Valve Replacement, run by Action, France at 1 site in France.
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 2 inclusion and 1 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 30 Jan 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 France. 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 Jean Philippe COLLET, MD, PhD (+33142162962, jean-philippe.collet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: 12 months). 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 30 Jan 2019.