Mitral valve incompetence Trials in Disease

Evaluation of optimal timing for heparin anticoagulation in patients undergoing transseptal heart procedures (TEER or left atrial appendage closure)

This trial is designed to find the safest and most effective timing for starting blood-thinning treatment in patients undergoing minimally invasive heart procedures. The study specifically focuses on two types of procedures: Transcatheter Edge-to-Edge Repair (TEER), which repairs a leaking heart valve, and Left Atrial Appendage Closure, which prevents blood clots in patients with irregular heartbeat. Both procedures require a technique called transseptal puncture, where doctors create a small opening between the upper chambers of the heart.

Main inclusion criteria:

• Adults aged 18 years or older
• Scheduled to undergo either TEER or Left Atrial Appendage Closure procedure
• Willing to attend all follow-up visits and follow the treatment plan
• Able to provide written informed consent

Main exclusion criteria:

• Active bleeding or high risk of bleeding
• Severe kidney or liver disease
• Blood clotting disorders that cannot be treated with standard medications
• Pregnancy or breastfeeding
• Recent stroke or mini-stroke (within the last 3 months)
• Active cancer requiring treatment
• Major surgery in the last 30 days
• Uncontrolled high blood pressure
• Life-threatening conditions requiring immediate treatment

Focus of the trial:

The study aims to determine the optimal timing for administering blood-thinning medication during heart procedures requiring transseptal puncture. Patients will receive either standard timing or a different timing schedule for blood-thinning medication. Throughout the trial, participants will undergo various monitoring procedures including special heart ultrasound imaging during the procedure and brain MRI scans 2 to 5 days afterward. The medical team will carefully monitor for any complications during the hospital stay and continue follow-up for 30 days after the procedure to check for heart-related events, stroke symptoms, or other health changes.

Investigational drugs:

The trial uses heparin sodium, a blood-thinning medication given by injection during the procedure. Heparin helps prevent dangerous blood clots from forming while doctors perform procedures that require crossing between chambers of the heart. The medication is administered as a solution containing 5,000 IU/ml. Additionally, a standard physiological saline solution is used during the procedure. Oral anticoagulants may also be part of the treatment plan for long-term protection against blood clots, particularly for patients who need ongoing management after their procedures.