Coagubility in severe mitral regurgitation: A within-patient evaluation of coagulation status before and after Mitral Valve Transcatheter Edge-to-Edge Repair.

Coagubility in severe mitral regurgitation: A within-patient evaluation of coagulation status before and after Mitral Valve Transcatheter Edge-to-Edge Repair. - POPular MR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56294

Enrollment

Registered

2023-11-10

Start date

2024-02-29

Completion date

Unknown

Last updated

2024-12-02

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

Conditions

Atrial fibrillation and leaking heart valve

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - >= 18 years old - Echocardiographic-proven (TTE) moderate or severe MR with a planned M-TEER procedure

Exclusion criteria

Exclusion criteria: - Patients who are unable to provide informed consent - Active malignancy excluding non-melanoma skin cancer - Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C) - Patients using, and unable to omit, nonsteroidal anti-inflammatory drugs, corticosteroids, or hormone replacement therapy - Known coagulopathy - Severe anaemia requiring blood transfusion or thrombocytopenia

Design outcomes

Primary

Measure	Time frame
The difference in coagulation activation, as measured with prothrombin fragments 1+2 and fibrinopeptide A+B, between baseline and 3 months after M-TEER	—

Secondary

Measure	Time frame
Markers of the coagulation cascade, thrombin generation, clot breakdown, and platelet activation will be measured before and 3 months after M-TEER: • Coagulation cascade: Prothrombin fragments 1+2, Thrombin-AntiThrombin complex (TAT), activated coagulation factors (Factor VIIa, Factor IXa, Factor Xa, Factor Xia, and Factor XIIa in complex with their respective natural inhibitors), thrombin-generation test (TGT) • Platelet reactivity: P-selectin expression, beta-thromboglobulin • Endothelial activation: VWF antigen, sICAM • Fibrinolysis activity: fibrinogen, soluble fibrin, plasmin-alfa-2-antiplasmin complex, D-dimer • VWF multimeres • Overall thrombus formation assessment (e.g. T-TAS AR chip) • Full blood count + differentiation • Clinical endpoints, i.e. bleeding, myocardial infarction, stroke/TIA, systemic embolism, all-cause death	—

Measure

Time frame

Markers of the coagulation cascade, thrombin generation, clot breakdown, and platelet activation will be measured before and 3 months after M-TEER: • Coagulation cascade: Prothrombin fragments 1+2, Thrombin-AntiThrombin complex (TAT), activated coagulation factors (Factor VIIa, Factor IXa, Factor Xa, Factor Xia, and Factor XIIa in complex with their respective natural inhibitors), thrombin-generation test (TGT) • Platelet reactivity: P-selectin expression, beta-thromboglobulin • Endothelial activation: VWF antigen, sICAM • Fibrinolysis activity: fibrinogen, soluble fibrin, plasmin-alfa-2-antiplasmin complex, D-dimer • VWF multimeres • Overall thrombus formation assessment (e.g. T-TAS AR chip) • Full blood count + differentiation • Clinical endpoints, i.e. bleeding, myocardial infarction, stroke/TIA, systemic embolism, all-cause death

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Countries

Netherlands

Outcome results