Optimal anticoagulation treatment during percutaneous correction of mitral valve regurgitation and left atrial appendage occlusion utilizing the intra-atrial septum access (STOP CLOT Trial)

Phase 1

• Conditions: Mitral regurgitation Atrial fibrilation Periprocedural anticoagulation strategy in patients treated with MitraClip implantation or Left Atrial Appendage Closure. The patients scheduled for MitraClip or LAAC procedure will be randomized to initiation of the unfractionated heparin either 15 minutes before or immediately after transseptal puncture.; MedDRA version: 20.0Level: LLTClassification code 10027718Term: Mitral regurgitationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-000442-18-PL
• Lead Sponsor: ational Institute of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

1.Age above 18 years
2.Planned treatment of mitral regurgitation with MitraClip implantation or planned left atrial appendage closure with Watchman Left Atrial Appendage Closure Device (Boston Scientific) or Amplatze LAA ocluder (Abbott)
3.The patient is willing to comply will all study procedures
4.The patient is willing to sign informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 246

Exclusion Criteria

1.Pregnant or breast feeding women or women with childbearing potential who do not agree to use at least two contraceptive measures (oral contraconception, mechanical contraconception, approved contraceptive implant, intrauterine device, tubal ligation) The criterion does not apply to postmenopausal women (defined as at least one year of no menstrual periods) at least 2 years prior to the enrollment or women who underwent surgical sterilization procedure. Otherwise female younger that 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)
3.INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists.
4.Last dose of new oral anticoagulant < 48 hours prior to the procedure.
5.Last dose of low molecular weight heparin <12 hours prior to the procedure.
6.Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic metalic prostheses)
7. Implanted cardiac devices for electrotherapy if:
- device or leads are labeled as MR unsafe
- the patient has implanted CRT or device with epicardial leads
- left disconnected electrodes or non-functional or damaged devices including those within abdominal wall
- the patient is pacemaker dependant
- the device was implanted or exchanged within 6 weeks prior to the MR examination
- device mulfunction identified during the control performed immediately prior to the MR examination
- low voltage of the device battery - the battery on the examination day should have at least 30% 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified