Clinical trial NCT05305612: Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Official title: Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Mitral Regurgitation
Atrial Fibrillation
Anticoagulation
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Medical Research Agency, Poland
name: Soft Communication, Poland
First posted: 2022-03-31
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to:

Early unfractionated heparin 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.

Late unfractionated heparin 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: Within 30 days from the index procedure
Secondary outcomes:
measure: Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization
timeFrame: during the hospitalization related to the index procedure but up to 30 days from randomization
measure: Intraprocedural fresh thrombus formation in the right of left atrium as assessed with periprocedural transsesophageal echocardiography
timeFrame: during index procedure
measure: Occurrence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure.
timeFrame: within 2-5 days post index procedure
measure: Major adverse cardiac and cerebrovascular events (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index procedure.
timeFrame: within 30 days from index procedure
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny
city: Katowice
country: Poland
facility: Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Study officials:
affiliation: National Institute of Cardiology
name: Jerzy Pręgowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: