Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Atrial Fibrillation Clinical Trial

— STOP CLOT  

Official title:

Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05305612
• Other study ID #: ABM/2020/1/00002
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 13, 2022
• Est. completion date: August 2025

Study information

• Verified date: July 2023
• Source: National Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 410
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulation
• Atrial Fibrillation
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Other:
• early anticoagulation
Anticoagulation prior to transseptal puncture
• late anticoagulation
Anticoagulation after transseptal puncture

Locations

Country	Name	City	State
Poland	Uniwersyteckie Centrum Kliniczne Gdanski Uniwersytet Medyczny	Gdansk
Poland	Górnoslaskie Centrum Medyczne im. Leszka Gieca Slaskiego 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	Warszawa

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Cardiology, Warsaw, Poland	Medical Research Agency, Poland, Soft Communication, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Intraprocedural fresh thrombus formation in the right of left atrium as assessed with periprocedural transsesophageal echocardiography		during index procedure
Secondary	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
Secondary	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