RecruitingNAINTERVENTIONAL

Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation

This study is looking at whether patients who have a common procedure for an irregular heartbeat condition called 'atrial fibrillation' can safely go home on the very same day. Usually, after this procedure, called pulmonary vein isolation, patients stay in the hospital overnight. The study compares this standard overnight stay with a new approach where patients go home hours after the procedure, using a special closing device for the small cuts made during the operation. Researchers want to see if same-day discharge is just as safe, doesn't lead to more unplanned doctor visits or readmissions, and if it could be more comfortable for patients and save money. The study will follow patients for a year.

At a glance

Status

Recruiting

Phase

Sponsor

University of Luebeck

Enrolment target

270

Start

20 Feb 2025

Estimated completion

15 Mar 2028

Atrial Fibrillation

What is this study about?

This study is about a common procedure called 'pulmonary vein isolation' (PVI) that helps people with a condition called atrial fibrillation. Atrial fibrillation causes your heart to beat irregularly, which can make you feel tired or breathless. During PVI, doctors use a thin, flexible tube (catheter) to reach your heart and create tiny scars to block the faulty electrical signals causing the irregular heartbeat. After this procedure, a small cut is made in your groin area to insert the catheter.

Currently, most people stay in the hospital overnight after PVI to make sure they are recovering well. However, this study is exploring a new idea: whether it's safe and practical for patients to go home on the very same day as their procedure. This 'same-day discharge' approach would involve using a special device to close the small cut in the groin, rather than the traditional methods like pressing on the area or using a stitch.

The main goal is to find out if going home on the same day is just as safe as staying overnight. The researchers will be carefully checking if patients who go home quickly have the same number of problems, like needing to go back to the emergency room or being readmitted to the hospital, compared to those who stay overnight. They also want to see if same-day discharge makes patients more comfortable and if it could help reduce healthcare costs. They will be watching participants for a full year to understand the long-term effects.

Key takeaways

This study compares going home the same day versus staying overnight after a heart procedure for atrial fibrillation.
It aims to see if same-day discharge is as safe and effective.
Researchers will check for unplanned doctor visits or readmissions.
The study also looks at patient comfort and potential cost savings.
Participation involves having your procedure and follow-up for up to 12 months.

Who may be eligible?

To join this study, you need to be at least 18 years old and be scheduled to have the 'pulmonary vein isolation' procedure for atrial fibrillation. For this procedure, doctors will need to access your blood vessels in your groin area using one or two entry points.

There are also some reasons why you might not be able to join. For example, if you have an active infection or inflammation near your groin, or if your blood platelet count (which helps your blood clot) is too low. Also, if your Body Mass Index (a measure of your weight in relation to your height) is very high (over 45) or very low (under 18), you wouldn't be able to take part.

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 'pulmonary vein isolation' procedure for atrial fibrillation?
Do you have any active infections or inflammation, especially near your groin?
Is your blood platelet count very low?
Is your Body Mass Index (BMI) between 18 and 45?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly chosen to either go home the same day after your 'pulmonary vein isolation' procedure, using a special closure device, or to stay overnight, which is the usual practice. You'll have your procedure as planned. The study will then keep track of your health for 30 days to see if you have any unplanned doctor visits or readmissions. They will also follow up for a full 12 months to check on your overall safety and recovery. This means you would have additional check-ups or contact with the study team during this time to see how you are doing.

Potential risks and benefits

Potential benefits of taking part could include the convenience of recovering in your own home sooner if you are in the same-day discharge group, and contributing to important research that could improve care for future patients. Potential risks are generally similar to those of the PVI procedure itself, such as bleeding or infection at the access site, with the study specifically checking if same-day discharge leads to any increased or different risks compared to an overnight stay. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Klinik für Rhythmologie
Verified postcode
Lübeck, Germany· Recruiting

Common questions

What is atrial fibrillation?

It's a common condition where your heart beats irregularly, which can sometimes make you feel unwell or tired.

What is 'pulmonary vein isolation'?

It's a procedure where doctors use a special tube to create tiny scars in your heart, helping to fix the irregular heartbeat.

What is 'same-day discharge'?

It means going home just a few hours after your procedure, rather than staying in the hospital overnight.

Will I get to choose if I go home the same day or stay overnight?

No, you'll be randomly assigned to one of the groups, like flipping a coin, to ensure a fair comparison.

How long will the study follow me?

The study will check on your recovery for 30 days, and then continue to follow your health for a full 12 months.

How to find out more

Roland R Tilz, Prof. Dr.

roland.tilz@uksh.de 0049451500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.