Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions (STOP CLOT)

Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atrial Fibrillation; Mitral Regurgitation; Anticoagulation
• Intervention / Treatment: Other: early anticoagulation; Other: late anticoagulation

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny
  • Katowice, Poland
    • Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego
  • Lublin, Poland
    • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Poznań, Poland, 60-355
    • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Warszawa, Poland
    • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age above 18 years
2. Planned TEER procedure or left atrial appendage closure
3. The patient is willing to sign informed consent and comply will all study procedure

Exclusion Criteria:

1. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.
2. Congenital or acquire bleeding disorders (i.e.diagnosed thrombophilia, bleeding diathesis, thrombocyopenia with platelet count <50 thousand/ml, INR elevated >1.5 in the last test prior to randomization)
3. INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists. (applies to the last INR value prior to randomization)
4. Last dose of new oral anticoagulant < 48 hours prior to the procedure (assessed at randomization)
5. Last dose of low molecular weight heparin <12 hours prior to the procedure (assessed at randomization)
6. Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic intraocular foreign boddies, ferromagnetic metalic prostheses)

7. Implanted cardiac devices for electrotherapy if:

   • device has epicardial leads
   • left disconnected leads or non-functional or damaged devices
   • device implanted within abdominal wall
   • the patient is pacemaker dependant (lack of escape rhytm >30/min)
   • the device was implanted or exchanged within 6 weeks prior to the MR examination
   • device mulfunction identified during the control performed prior to the MR examination, that in the opinion of electrophysiologist team may impact the safety of MR imaging
   • low voltage of the device battery - the battery on the examination day should have at least 20% of the voltage value between the nominal value and elective replacement indicator (ERI) value, or the expected battery life calculated by the device should equal or exceed one year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: early anticoagulation; Anticoagulation prior to transseptal puncture
Active Comparator: 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.	Other: late anticoagulation; Anticoagulation after transseptal puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. MACCE 2. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography 3. Occurrence of new ischemic lesions with diameter ≥4 mm in brain MR performed 2-5 days after procedure	Major adverse cardiac and cerebrovascular events (MACCE) will include: death, stroke, TIA, peripheral embolization, myocardial infarction within 30 days from the index procedure.	Within 30 days from the index procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization	during the hospitalization related to the index procedure but up to 30 days from randomization
Intraprocedural fresh thrombus formation in the right of left atrium as assessed with periprocedural transsesophageal echocardiography	during index procedure
Occurrence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure.	within 2-5 days post index procedure
Major adverse cardiac and cerebrovascular events (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index procedure.	within 30 days from index procedure

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Warsaw, Poland
• Collaborators: Medical Research Agency, Poland; Soft Communication, Poland
• Investigators: Principal Investigator: Jerzy Pręgowski, MD, PhD, National Institute of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Valve Diseases; Atrial Fibrillation; Mitral Valve Insufficiency
• Other Study ID Numbers: ABM/2020/1/00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: to be defined
• IPD Sharing Time Frame: IPD sharing will be considered after study completion and publication of the results.
• IPD Sharing Access Criteria: to be defined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No