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

Verified siteRegistered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on finding the best timing for starting anticoagulation treatment in patients who undergo heart procedures requiring transseptal puncture (a technique that involves creating a small hole between the upper chambers of the heart). The study specifically looks at two types of procedures: Transcatheter Edge-to-Edge Repair (a minimally invasive procedure to repair a leaking heart valve) and Left Atrial Appendage Closure (a procedure to prevent blood clots in patients with irregular heartbeat).

The study uses two medications: Heparin, which is a blood-thinning medication given by injection, and physiological saline solution, which is a sterile salt water solution used during medical procedures. The main purpose is to determine when it is safest and most effective to start blood-thinning treatment in patients undergoing these heart procedures.

During the study, patients will receive either standard timing of blood-thinning medication or a different timing schedule. The effects will be monitored through various medical examinations, including imaging of the heart and brain, to ensure patient safety and evaluate the effectiveness of different timing approaches. The study will track any complications or adverse events that might occur during and after the procedures.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial procedure preparation
You will undergo either a Transcatheter Edge-to-Edge Repair (TEER) or Left Atrial Appendage Closure (LAAC) procedure.
Your doctor will explain the specific type of heart procedure planned for your case.
Step 2
Medication administration
You will receive heparin sodium through injection during the procedure.
The medication will be given as a solution containing 5,000 IU/ml.
A standard saline solution (9 mg/ml) will also be administered during the procedure.
Step 3
Medical imaging
During the procedure, images of your heart will be taken using TEE (a special ultrasound that looks at your heart from inside the food pipe).
Between 2 to 5 days after the procedure, you will have a brain MRI (magnetic resonance imaging) scan.
Step 4
Hospital stay monitoring
Your medical team will monitor for any complications during your hospital stay.
They will check for any bleeding issues or other potential complications.
Step 5
Follow-up period
Your health will be monitored for 30 days after the procedure.
The medical team will check for any heart-related events, stroke symptoms, or other health changes during this time.

Who can join the trial?

7 criteria

Must be at least 18 years old
Must be scheduled for either:
- TEER (Transcatheter Edge-to-Edge Repair - a minimally invasive heart valve repair procedure) or
- LAAC (Left Atrial Appendage Closure - a procedure to seal off a small pouch in the heart)
- Must be willing to follow all study requirements, including:
  - Attending all scheduled follow-up visits
  - Following the treatment plan as prescribed
  - Must be able and willing to provide written informed consent to participate in the study
  - Can be either male or female

Who cannot join the trial?

14 criteria

Patients under 18 years of age cannot participate in the study
Patients with active bleeding or high risk of bleeding
Patients with severe kidney disease (poor kidney function)
Patients with liver failure (poor liver function)
Patients with blood clotting disorders that cannot be treated with standard medications
Pregnant or breastfeeding women
Patients who had a stroke or mini-stroke (temporary blood flow disruption to the brain) in the last 3 months
Patients with active cancer requiring treatment
Patients who cannot take blood-thinning medications
Patients who have had major surgery in the last 30 days
Patients who cannot provide informed consent
Patients participating in other clinical trials
Patients with uncontrolled high blood pressure
Patients with life-threatening conditions requiring immediate treatment

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gornoslaskie Centrum Mwdyczne
Verified
Katowice, Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Responsive
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

Trial locations

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Investigated drugs

Heparin This is a blood-thinning medication used to prevent blood clots during and after medical procedures. It helps protect patients from developing dangerous clots while undergoing heart procedures that require crossing between chambers of the heart. Oral anticoagulants These are blood-thinning medications taken by mouth to prevent blood clots. They are commonly used in patients who need long-term protection against blood clots, particularly in conditions involving the heart's chambers. Note: While specific medications aren't directly mentioned in the source data, these medications are typically involved in structural transseptal interventions and anticoagulation management during such procedures. The trial aims to determine the best timing for using these medications during specific heart procedures.

Heparin Sodium

What is already known about the treatment

Heparin
A widely used injectable anticoagulant medication that plays a crucial role in preventing blood clots during medical procedures, particularly in structural heart interventions like Transcatheter Edge-to-Edge Repair (TEER) and Left Atrial Appendage Closure. This naturally occurring substance works by binding to and activating antithrombin III, which inhibits blood clotting factors and prevents clot formation. Heparin belongs to the class of anticoagulant medications and is administered intravenously during procedures, with its effects being closely monitored through activated clotting time measurements.
Warfarin
An oral anticoagulant medication commonly used in patients who require long-term blood clot prevention before and after structural heart procedures. This medication works by interfering with vitamin K-dependent clotting factor synthesis in the liver, effectively reducing the blood's ability to form clots. As a member of the vitamin K antagonist class of medications, warfarin requires regular monitoring through blood tests (INR) to maintain the proper level of anticoagulation and prevent bleeding complications.

Investigated diseases

Stroke
A condition where blood flow to the brain is interrupted, causing brain cells to die due to lack of oxygen and nutrients. The damage can affect various brain functions including movement, speech, and memory. Strokes can occur either when blood vessels are blocked or when they burst.
Transient Ischemic Attack (TIA)
A temporary interruption of blood flow to part of the brain, also known as a "mini-stroke." Symptoms are similar to stroke but typically resolve within 24 hours. The condition causes temporary weakness, speech difficulties, or visual disturbances.
Myocardial Infarction
A condition where part of the heart muscle is damaged due to reduced blood flow to the heart. It occurs when one or more coronary arteries become blocked, preventing oxygen-rich blood from reaching parts of the heart muscle. The affected heart tissue may become permanently damaged.
Peripheral Embolization
A condition where a blood clot travels through the bloodstream and blocks a blood vessel in a part of the body away from where it formed. The blockage can occur in limbs, organs, or other body parts, reducing blood flow to affected areas.
Cardiac Tamponade
A serious condition where fluid accumulates in the space around the heart, putting pressure on the heart muscle. This pressure prevents the heart chambers from filling properly with blood, reducing the heart's ability to pump effectively.