RecruitingOBSERVATIONAL

The DefiPace Study

This study, called The DefiPace Study, is looking into a common heart rhythm issue known as atrial fibrillation (AF) that can happen after heart surgery. It's happening in two main parts. First, researchers want to see how AF is currently managed in patients after their heart operations. Then, they will look at how a new system called DefiPace works. This system uses low-energy electrical pulses to help reset the heart's rhythm if AF occurs and can also help prevent it from coming back. The study will not involve giving patients any new treatments; instead, it will observe what happens in real-life medical practice to help improve care for people having heart surgery.

At a glance

Status

Recruiting

Sponsor

Institut für Pharmakologie und Präventive Medizin

Enrolment target

450

Start

28 Mar 2023

Estimated completion

31 Aug 2026

Post-operative Atrial Fibrillation POAF

What is this study about?

Heart surgery is a major operation, and sometimes, afterwards, people can develop a fast and irregular heartbeat called atrial fibrillation, often shortened to AF. This can be a bit worrying and means an extended stay in hospital. This study, called The DefiPace Study, is trying to understand more about AF after heart surgery and how it's treated.

It's organised in two parts. The first part simply watches how doctors currently treat AF in about 50 patients who develop it after surgery. This helps us understand what is considered standard care right now. The second part of the study then looks at how a new system, called DefiPace, is used. This system is designed to correct the irregular heartbeat with very gentle electrical pulses and then help keep the heart rhythm regular afterwards, like a special kind of pacemaker.

The main goal is to gather information about how DefiPace works in real life when doctors decide to use it. This isn't a study where you are given a new medicine or treatment you wouldn't otherwise get. Instead, it carefully records information about patients who are already having certain heart surgeries and would either receive standard care or have the DefiPace system included as part of their treatment plan. The information gathered will help doctors better understand how to prevent and manage AF after heart operations.

Key takeaways

The study looks at heart rhythm issues after heart surgery.
It observes existing medical care, not new treatments.
Information is collected during your hospital stay.
A phone call follow-up happens if you get atrial fibrillation.
Participation is voluntary and won't affect your treatment.

Who may be eligible?

To be considered for this study, you need to be having planned open-chest heart surgery, specifically bypass surgery or valve surgery. You must be at least 18 years old. If you're having only bypass surgery, you need to be at least 70, and if it's valve surgery, you need to be at least 60 years old. You also need to agree to take part by signing a consent form.

If you're in the second part of the study (Phase B), it's also important that your doctors are planning to implant a specific temporary device during your surgery that could work with the DefiPace system.

However, there are reasons you couldn't join. For example, if you already have a history of atrial fibrillation, if you have a pacemaker or defibrillator, if you're having keyhole surgery (not open-chest), or if you've had a stroke recently (in the last three months). Pregnancy or a history of certain heart infections (endocarditis) would also mean you couldn't take part. The study is open to both men and women.

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 having planned open-chest heart bypass or valve surgery?
Are you at least 18 years old (with specific age rules for bypass/valve surgery)?
Do you *not* currently have or have a history of atrial fibrillation?
Do you *not* have a pacemaker or defibrillator?
Are you comfortable signing a consent form to take part?

Answer every question to see your result.

What does participation involve?

If you take part in this study, it mainly involves your doctors collecting information about your health during your planned heart surgery and while you are in the hospital. This includes details about your operation, any pacing treatments you receive, and if you develop atrial fibrillation, how it's managed.

For some patients who develop atrial fibrillation after surgery, there will be a follow-up phone call about a month after your operation to check how you're doing. This study does not involve any extra clinic visits, blood tests, or new medications beyond what your doctor would normally recommend for your care. The total duration of your participation will be from your surgery until you leave the hospital, plus a potential phone call about 30 days later for those who experienced atrial fibrillation.

Potential risks and benefits

This study doesn't involve any new treatments or procedures beyond what your doctors already plan for your care. Therefore, there are no additional physical risks directly from participating in the study itself. Any risks would be those associated with your planned heart surgery and recovery, which your medical team will discuss with you. The potential benefit is that the information gathered could help improve care for future patients undergoing heart surgery who might develop atrial fibrillation. Remember, taking part in any study is entirely voluntary, and you are free to withdraw at any time without it affecting your medical care.

Locations (10)

Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
Universitätsklinikum Erlangen
Verified postcode
Erlangen, Germany· Recruiting
Klinikum Nürnberg
Verified postcode
Nuremberg, Germany· Recruiting
University Hospital of Würzburg
Verified postcode
Würzburg, Germany· Recruiting
Oldenburg Hospital AöR / Medical Campus University of Oldenburg
Verified postcode
Oldenburg, Germany· Recruiting
Heart Center Dresden GmbH University Hospital
Verified postcode
Dresden, Germany· Recruiting
Albert-Ludwigs-Universitaet Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Hannover Medical School
Verified postcode
Hanover, Germany· Recruiting
University Hospital Jena
Verified postcode
Jena, Germany· Recruiting
University Hospital Ulm
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is atrial fibrillation (AF)?

AF is when your heart beats very fast and irregularly. It's a common problem after heart surgery.

Will I receive a special treatment if I join?

No, this study observes standard care or existing treatment plans. It doesn't give you any new or experimental treatments.

What information will be collected about me?

Doctors will collect details about your surgery, any heart pacing treatments, and how any AF is managed while you are in hospital.

How long will I be involved in the study?

From your surgery until you leave the hospital. If you develop AF, you'll also get a follow-up phone call about a month later.

Can I change my mind about taking part?

Yes, you can decide to leave the study at any time without explaining why, and it won't affect your medical care.

How to find out more

Susanne Nitz, PhD

susanne.nitz@ippmed.de +49 447185033 Official trial record

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