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Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Study acronym: STOP CLOT
StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 7 months later May 2025 → Jan 2027
See other at-risk trials from National Institute of Cardiology, Warsaw, Poland

Record History

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  1. Primary completion pushed from May 2025 to Jan 2027 Show 4 more changesShow less
    • Study completion pushed from Aug 2025 to Mar 2027
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints revised (4)
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv7
  3. Collaborators revised (2)v6
  4. Study sites revised (5)v5
  5. Collaborators expanded, about 7 wordsv4
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  1. Eligibility criteria expanded, about 4 wordsv3
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Mar 2022 to Mar 13, 2022
    • Site contacts updated at 3 of 5 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The transcatheter edge to edge mitral valve repair (TEER) and left atrial appendage closure (LAAC) are the interventional cardiology procedures that require periprocedural anticoagulation with unfractionated heparin (UFH). The UFH is administered either before or immediately after transseptal puncture, at the discretion of the operator The aim of the study is to establish the optimal timing of initiation of periprocedural anticoagulation in patients undergoing structural heart interventions requiring transseptal puncture (TEER and LAAC), Patients who undergo TEER implantation or LAAC procedure will be randomized to two groups: 1. Early UFH administration. The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 5 minutes prior to the start of the TSP. 2. Late UFH administration. The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium.
Trial Details
NCT Number NCT05305612
Lead Sponsor National Institute of Cardiology, Warsaw, Poland
Collaborators: Medical Research Agency, Poland, Soft Communication, Poland
Conditions
(from sponsor)		 Mitral Regurgitation, Atrial Fibrillation, Anticoagulation
Related terms Atrial Fibrillation, Mitral Valve Insufficiency
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov