Active not recruitingNAINTERVENTIONAL

StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation

This study is looking at the best way to close up the small opening in your blood vessel after a common heart procedure called catheter ablation for atrial fibrillation (AF). After the procedure, it's important to seal the area to stop bleeding. We're comparing a special disc called StatSeal with a traditional stitch, known as a figure-of-eight suture. The main goal is to see if using the StatSeal helps people get up and walk around sooner. We'll also check if one method leads to less bleeding, quicker hospital discharge, fewer problems, and overall makes patients more comfortable. This research aims to find out which closing method is better for patients recovering from AF ablation.

At a glance

Status

Active not recruiting

Phase

Sponsor

Mid and South Essex NHS Foundation Trust

Enrolment target

160

Start

03 Jan 2025

Estimated completion

01 Jan 2026

Atrial Fibrillation (AF)Vascular Access

What is this study about?

When you have a procedure called catheter ablation for atrial fibrillation (AF), doctors put thin tubes (catheters) into a blood vessel, usually in your groin, to reach your heart. After the procedure, these small openings in your blood vessel need to be closed properly to prevent any bleeding. This study is comparing two different ways of doing this.

One method uses a special disc called StatSeal. The other method uses a traditional stitch, similar to how a surgeon would close a wound, called a figure-of-eight suture. Both of these methods are commonly used, but we want to see if one works better for patients.

The main thing this study wants to find out is whether using the StatSeal helps you get up and walk around faster after your procedure. This is important because getting moving sooner can often help with your recovery. The study will also look at how quickly any bleeding stops, if you can go home sooner, if there are fewer problems, and if you feel more comfortable with one method over the other. By comparing these two options, we hope to improve how patients recover after AF ablation procedures.

Key takeaways

Compares two ways to close blood vessels after AF ablation.
Aims to see if one method helps patients walk sooner.
Also looking at bleeding, comfort, and discharge times.
Both methods are standard and commonly used.
Your safety will be closely monitored throughout the study.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and having a specific heart procedure called catheter ablation for atrial fibrillation. You must also be able to understand the study and agree to be involved.

You might not be able to join if you have certain health conditions. For example, if you have an infection or inflammation near your groin, or if you have a low number of blood clotting cells (platelets). People with very high or very low body weight, or those who had certain problems during their procedure, might also not be eligible. This includes if there were difficulties getting into the blood vessel, if you had a lot of bleeding, or if you have a history of bleeding disorders.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a catheter ablation for atrial fibrillation?
Do you have a current infection near your groin area?
Do you have a history of bleeding or clotting problems?
Is your body weight (BMI) within the normal range?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive either the StatSeal device or the figure-of-eight stitch after your atrial fibrillation ablation procedure. This is like flipping a coin, so it's fair. Both methods are standard care. You won't be given any extra medications for the study.

Researchers will closely monitor how quickly you can get up and walk after your procedure. They'll also check how long it takes for any bleeding to stop, when you're ready to go home, if you have any side effects, and how comfortable you feel. All participants will be carefully looked after throughout their hospital stay. The study period would be essentially your time in the hospital recovering from the ablation procedure itself.

Potential risks and benefits

There is a potential benefit that this study could help find a better way to recover after AF ablation, benefiting future patients. For you specifically, both methods are standard and widely used, so you would be receiving care you would get anyway. There are always risks with any medical procedure, including the small risks linked to closing the blood vessel such as bleeding or bruising, regardless of which method is used. However, you will be closely monitored for your safety throughout the study. Remember, taking part in any study is completely your choice, and you can withdraw at any time without affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Essex Cardiothoracic Centre
Verified postcode
Basildon, United Kingdom
East Sussex Healthcare NHS Trust
Verified postcode
Eastbourne, United Kingdom
Norfolk and Norwich University Hospital
Verified postcode
Norwich, United Kingdom

Common questions

What is 'atrial fibrillation ablation'?

It's a procedure where doctors use thin tubes to fix an irregular heartbeat from your heart, helping it beat normally again.

What's the main thing this study is looking at?

It wants to see if one method of closing the small opening in your blood vessel after the procedure helps you get up and walk sooner.

Will I get extra medicine in this study?

No, you won't get any extra medication. The study is only comparing two ways to close the blood vessel after your procedure.

Are the closing methods new or untried?

No, both the StatSeal and the figure-of-eight stitch are standard and commonly used methods for closing blood vessels.

Can I change my mind and leave the study?

Yes, you are free to stop participating at any time, and it won't affect your medical care.