Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

NCT ID: NCT05305612

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-13
• Study Completion Date: 2025-08-31

Brief Summary

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.

Conditions

Mitral Regurgitation; Atrial Fibrillation; Anticoagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

early anticoagulation

Intervention Type: OTHER

Anticoagulation prior to transseptal puncture

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.

Group Type: ACTIVE_COMPARATOR

late anticoagulation

Intervention Type: OTHER

Anticoagulation after transseptal puncture

Interventions

early anticoagulation

Anticoagulation prior to transseptal puncture

Intervention Type: OTHER

late anticoagulation

Anticoagulation after transseptal puncture

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Agency, Poland

OTHER_GOV

Sponsor Role: collaborator

Soft Communication, Poland

UNKNOWN

Sponsor Role: collaborator

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerzy Pręgowski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology

Locations

Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny

Gdansk, , Poland

Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego

Katowice, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, , Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, , Poland

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, , Poland

Countries

Poland

References

Pregowski J, Pracon R, Mioduszewska A, Skowronski J, Sondergaard L, Mintz GS, Capodanno D, Kim SW, De Baker O, Wacinski P, Wojakowski W, Rdzanek A, Grygier M, Chmielecki M, Franco LN, Stoklosa P, Firek B, Marczak M, Milosz B, Chmielak Z, Demkow M, Witkowski A. Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial. Am Heart J. 2024 May;271:68-75. doi: 10.1016/j.ahj.2024.02.015. Epub 2024 Feb 22.

Reference Type: DERIVED

PMID: 38401649 (View on PubMed)

Other Identifiers

ABM/2020/1/00002

Identifier Type: -

Identifier Source: org_study_id