Authorised Phase III and phase IV (Integrated) periprocedural anticoagulant treatment in patients treated with TEER or transcatheter left atrial appendage closure surgery

Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions (STOP CLOT Trial)

EU CTIS ID: 2024-516376-15-00

What this study is testing

Determining the optimal timing for initiating anticoagulation in patients undergoing interventional procedures requiring transseptal puncture, such as Transcatheter Edge-to-Edge Repair (TEER) and Left Atrial Appendage Closure (LAAC).

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Age above 18 years. 2. Planned mitral TEER * or LAAC † procedure. 3. Participant expresses willingness to adhere to the study protocol, especially as specified by the protocol for follow-up visits.. 4. The patient is willing to sign informed consent

You likely can't join if

  • 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 acquired bleeding disorders (i.e., diagnosed thrombophilia, bleeding diathesis, thrombocytopenia with platelet count <50 thousand/ml, INR elevation >1.5 due to the liver disease). 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 bodies, ferromagnetic metallic 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 dependent (lack of escape rhythm >30/min). - the device was implanted or exchanged within 6 weeks prior to the MR. examination - device malfunction 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.