Valvular & structural heart disease
Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial
Study context
- Population
- Patients scheduled for transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC)planned
- Participants
- 410 patients
- Planned comparison
- Early vs late unfractionated heparin (UFH) administration relative to transseptal puncture
- Primary endpoint
- Composite of:
- MACCE (death, stroke, TIA, MI or peripheral embolization) within 30 days
- Intraprocedural fresh thrombus in right or left atrium on periprocedural TEE
- New ischemic lesions (diameter ≥4 mm) on brain MRI 2 to 5 days after the procedure
- Follow-up
- 30 days post-procedure (MACCE); MRI 2 to 5 days after the procedure
Methodological detailsmulticentre, prospective, double-blind, placebo-controlled, 1:1 randomisation, prespecified preliminary analysis after first 196 randomised subjects, Safety endpoint: moderate or severe bleeding complications during index hospitalization, Study nurse responsible for randomization and UFH/placebo preparation not involved in patient care
- Multicentre
- Prospective
- Double-blind
- Placebo-controlled
- 1:1 randomisation
- Prespecified preliminary analysis after first 196 randomised subjects
- Safety endpoint: moderate or severe bleeding complications during index hospitalization
- Study nurse responsible for randomization and UFH/placebo preparation not involved in patient care
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial. Am Heart J. Published 22 February 2024. doi:10.
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