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ATLANTIS Protamine - Antagonization of heparin with protamine sulfate to reduce all neurologic ischemic and hemorrhagic events after transcatheter aortic valve implantation for aortic stenosis: the ATLANTIS Protamine study.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504511-32-00
Acronym
APHP211046
Enrollment
940
Registered
2023-12-15
Start date
2025-05-24
Completion date
Unknown
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any patients ≥18 years old, eligible for transfemoral TAVI with coverage for medical insurance

Brief summary

The primary endpoint is defined as the first occurrence, from procedure to hospital discharge, of any event of the composite of all-cause mortality, type 2, 3 or 4 bleeding, major or minor vascular complications, stroke or TIA, myocardial infarction or any red-blood transfusion. The primary endpoint will be blindly determined by a clinical event committee according to the valve Academic Research Consortium-3 (VARC-3 classifications)

Detailed description

Assessment of length of in-hospital stay in days post TAVI procedure, Assessment of the occurrence from procedure to hospital discharge of: Type 2, 3 or 4 bleeding according to the VARC 3 criteria or any red blood cell transfusion of minor or vascular complications. Type 2, 3 or 4 bleedings or red blood cell transfusion. Any red blood cell transfusion Type 2, 3 or 4 bleedings, Assessment of an interaction in the impact of systematic antagonization according to the use or not of an echo-guided femoral puncture and/or arterial radial access. These subgroups are defined at the time of randomization by stratification., Assessment of the occurrence from procedure to hospital discharge of: Death or type 2, 3 or 4 bleedings Any kidney injury, stage 2 to 4 according to the KDIGO definition Death, type 2, 3 or 4 bleedings or stroke De a th, VARC 3 type 2-3-4 bleeding or Any red blood cell transfusion, MI or stroke Or TIA Any myocardial infarction, stroke or TIA Type 3 or 4 bleeding Type 2 bleeding Minor vascular complications Access site and access related vascular injury according to VARC-3 criteria

Interventions

DRUGPROTAMINE CHOAY 1000 U.A.H./ml
DRUGsolution injectable

Sponsors

Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is defined as the first occurrence, from procedure to hospital discharge, of any event of the composite of all-cause mortality, type 2, 3 or 4 bleeding, major or minor vascular complications, stroke or TIA, myocardial infarction or any red-blood transfusion. The primary endpoint will be blindly determined by a clinical event committee according to the valve Academic Research Consortium-3 (VARC-3 classifications)

Secondary

MeasureTime frame
Assessment of length of in-hospital stay in days post TAVI procedure, Assessment of the occurrence from procedure to hospital discharge of: Type 2, 3 or 4 bleeding according to the VARC 3 criteria or any red blood cell transfusion of minor or vascular complications. Type 2, 3 or 4 bleedings or red blood cell transfusion. Any red blood cell transfusion Type 2, 3 or 4 bleedings, Assessment of an interaction in the impact of systematic antagonization according to the use or not of an echo-guided femoral puncture and/or arterial radial access. These subgroups are defined at the time of randomization by stratification., Assessment of the occurrence from procedure to hospital discharge of: Death or type 2, 3 or 4 bleedings Any kidney injury, stage 2 to 4 according to the KDIGO definition Death, type 2, 3 or 4 bleedings or stroke De a th, VARC 3 type 2-3-4 bleeding or Any red blood cell transfusion, MI or stroke Or TIA Any myocardial infarction, stroke or TIA Type 3 or 4 bleeding

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026