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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Gornoslaskie Centrum Mwdyczne Katowice Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Uxfkstbixwtgrj Clbhdtx Kzczzzmie Gdansk Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not yet recruiting
14.03.2022

Trial locations

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.

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.

Trial ID:
2024-516376-15-00
Protocol code:
ABM/2020/1/00002
NCT ID:
NCT05305612
Trial Phase:
Human Pharmacology (Phase I) – Other

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