RecruitingOBSERVATIONAL

Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation

This study is about a heart treatment called 'pace and ablate' for people with an irregular heartbeat, atrial fibrillation (AF). This treatment uses a pacemaker and a procedure called ablation when medicines haven't worked. While it helps control the heart rate, sometimes the pacemaker can weaken the heart muscle, a side effect called 'pacing-induced cardiomyopathy'. The study looks back at records from over 2,000 patients who had this treatment in the UK and other countries. Its main goals are to identify which patients are most likely to develop this heart-weakening side effect, find better ways to pace the heart to prevent it, and understand the overall costs of this treatment in different healthcare systems.

At a glance

Status

Recruiting

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

2,600

Start

05 Jan 2011

Estimated completion

31 Dec 2027

Atrial Fibrillation (AF)Cardiomyopathy, Secondary Pacing-Induced Cardiomyopathy Heart Failure

What is this study about?

This research project focuses on a specific heart treatment called 'pace and ablate' for people who have an irregular and often fast heartbeat known as atrial fibrillation (AF). If medicines or other procedures haven't successfully managed AF, doctors might suggest this approach. It involves fitting a permanent pacemaker (to ensure the heart beats regularly) and then performing a procedure called AV node ablation, which blocks the faulty electrical signals causing the fast AF.

While this treatment can greatly improve symptoms and quality of life for many, there's a known potential side effect: the way the pacemaker stimulates the heart over many years can sometimes weaken the main pumping chamber, a condition called 'pacing-induced cardiomyopathy'. This study wants to understand this better. Researchers are looking at existing patient records from five hospitals across Switzerland, the UK, and Poland, involving over 2,000 patients who had this procedure since 2011.

The main aims of this study are threefold. Firstly, they want to confirm if a previously developed tool can accurately predict which patients are most likely to develop the heart-weakening side effect. Secondly, they want to compare how the 'pace and ablate' procedure is done in different hospitals and countries, and what the results are. Finally, they are looking at the overall costs involved with this treatment strategy, including hospital stays, device costs, and any follow-up care needed. The ultimate goal is to help doctors make better decisions about who should receive this treatment and how to reduce potential side effects.

Key takeaways

The study looks at past records of over 2,000 patients who had a heart treatment called 'pace and ablate'.
It aims to find out which patients might get a side effect where the heart muscle weakens.
Researchers want to improve how pacemakers are used to prevent this side effect.
They are also looking at the overall costs of this treatment in different healthcare systems.
No new treatments are being tested, and no patients are directly involved in new procedures.
The findings could help doctors give better care to future patients with irregular heartbeats.

Who may be eligible?

This study is looking back at the information of people who have already had a specific heart procedure. This means you wouldn't directly join or be tested for this study in the usual way, as the information is gathered from past medical records.

However, if you had this procedure, your information might be included if you were 18 years old or older at the time of your heart procedure. You would also need to have had atrial fibrillation and received the 'pace and ablate' treatment, which involves having a pacemaker fitted and the AV node ablation procedure. Importantly, your medical records must contain details about how well your heart was pumping (your 'ejection fraction') before the procedure.

Your information would not be included if you had specifically told the hospital that your health records shouldn't be used for research. Otherwise, if you met the above points, your anonymous data might be part of this important study.

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.

Were you 18 years old or older when you had your heart procedure?
Did you have an irregular heartbeat (atrial fibrillation)?
Did you receive the 'pace and ablate' treatment (pacemaker and AV node ablation)?
Does your hospital have records of your heart's pumping function (ejection fraction) before the procedure?
Did you not specifically tell your hospital that your health records shouldn't be used for research?

Answer every question to see your result.

What does participation involve?

Since this is a 'retrospective' study, meaning it looks back at existing medical records, patients don't 'participate' in the traditional sense. You wouldn't need to visit the hospital, have extra tests, take new medications, or attend follow-up appointments specifically for this study. The researchers are simply collecting and reviewing information that's already in your hospital notes. Your identity remains private, as your information is anonymised to protect your privacy.

Potential risks and benefits

Because this study only involves looking at existing, anonymous medical records, there are no direct risks or benefits to individual patients. No one will receive new treatments or be asked to do anything different as a result of being included. The potential benefit is for future patients: the study hopes to give doctors clearer guidance on who might be at risk of certain side effects from the 'pace and ablate' treatment, and how to improve care for people with atrial fibrillation. This could lead to better treatment choices and fewer complications for others in the future.

Locations (5)

Silesian Centre for Heart Diseases
Verified postcode
Zabrze, Poland· Recruiting
Inselspital, Universitätsspital Bern
Verified postcode
Bern, Switzerland· Recruiting
University Hospital Basel
Verified postcode
Basel, Switzerland· Recruiting
Geneva University Hospitals
Verified postcode
Geneva, Switzerland· Recruiting
Liverpool Heart and Chest Hospital
Verified postcode
Liverpool, United Kingdom· Recruiting

Common questions

What is 'atrial fibrillation'?

Atrial fibrillation (AF) is a common heart condition that causes an irregular and often abnormally fast heart rate. This can lead to symptoms like palpitations, shortness of breath, and tiredness.

What does 'pace and ablate' mean?

It's a two-part treatment for AF. 'Pace' means fitting a pacemaker to keep your heart beating regularly. 'Ablate' means a procedure to block faulty electrical signals in your heart that cause AF.

What is 'pacing-induced cardiomyopathy'?

This is a potential side effect where a pacemaker, over time, can cause the heart muscle to weaken and not pump blood as effectively. This study aims to find out who is most at risk.

Are patients directly involved in this study?

No, patients are not directly involved. The study uses existing, anonymised medical records from people who have already had the 'pace and ablate' procedure. You wouldn't have any extra appointments or treatments.

How will this study help people?

By understanding who is most at risk of heart-weakening side effects and how treatments compare, the study aims to help doctors make better decisions for future patients needing 'pace and ablate' treatment, leading to safer and more effective care.

How to find out more

Nikola A Kozhuharov, PD Dr. med.

nikola.kozhuharov@insel.ch +41 76 443 90 86 Official trial record

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