Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention
BIO TAVI
1 other identifier
observational
600
1 country
1
Brief 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). 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 30, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 30, 2019
January 1, 2019
5.6 years
May 30, 2016
January 29, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
12 months
Secondary Outcomes (1)
mean pressure transprosthetic gradient
within ten days after valve replacement
Eligibility Criteria
Patient undergoing TAVR
You may qualify if:
- patient undergoing TAVR intervention
- agreement given
You may not qualify if:
- severe thrombopenia ( \<40.10\^9/L)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Action, Francelead
Study Sites (1)
Hopital Pitie Salpetriere
Paris, 75013, France
Biospecimen
Platelet poor plasma for von Willebrandt Factor further evaluation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2016
First Posted
June 24, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
January 30, 2019
Record last verified: 2019-01