RecruitingNAINTERVENTIONAL

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

The PROTECT-HF study is comparing two different ways to use pacemakers for people with a slow heartbeat, a condition called bradycardia. One way is the standard method, called 'right ventricular pacing'. The other is a newer method called 'physiological pacing', which tries to mimic the heart's natural electrical system more closely. Researchers will study 2600 patients, randomly assigning them to receive one of these two pacing methods. They want to find out which method is better at keeping hearts healthy over time. The study will also look at how these pacing methods affect the heart's pumping ability.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

2,600

Start

05 Jun 2023

Estimated completion

04 Dec 2029

Bradycardia Pacing Right Ventricular Pacing His Bundle Pacing Left Bundle Branch Area Pacing

What is this study about?

Heart pacemakers are small devices that help your heart beat at a healthy rhythm if it's too slow. This study, called PROTECT-HF, is looking at two main ways doctors can set up these pacemakers for people with a slow heartbeat.

One way is the standard approach, called 'right ventricular pacing'. This has been used for many years. The other way is newer and is called 'physiological pacing'. This method tries to make the pacemaker work more like your heart's natural electrical system. Doctors want to understand if this newer approach is better for your heart in the long run compared to the standard method. The aim is to find the best way to help people with slow heartbeats live healthier lives.

Researchers will involve 2600 patients in this study. Patients will be randomly chosen to receive either the standard pacing or the newer physiological pacing. This helps make the study fair and reliable. They will also keep a close eye on how patients are doing at regular check-ups to see the effects of each pacing method. A smaller group of 500 patients will also have special scans (echocardiograms) to see how the pacemaker affects their heart's pumping over two years.

Key takeaways

This study compares two pacemaker methods for slow heartbeats.
It aims to find the best pacing method for long-term heart health.
2600 patients will be randomly assigned to one of two pacing types.
Regular check-ups will monitor patient progress.
A sub-study will use heart scans to understand how pacing affects the heart.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you need to be an adult (over 18 years old) who needs a pacemaker because your heart beats too slowly. Your doctor will have recommended a pacemaker for a specific reason, such as certain types of heart block or a very slow, irregular heartbeat.

There are also some reasons why you might not be able to join. For example, if your slow heartbeat is very mild and unlikely to need much pacing, or if you are pregnant, you won't be able to participate. Also, if other serious health conditions mean your doctors expect you to live for less than a year, or if you can't give your clear permission to join, you wouldn't be eligible.

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 over 18 years old?
Do you need a pacemaker for a slow heartbeat (bradycardia)?
Is your doctor recommending a pacemaker due to heart block or other guidelines?
Are you currently not pregnant?
Are you able to give your informed consent?
Do doctors expect your life expectancy to be more than one year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the PROTECT-HF study, you will first have a pacemaker fitted. At this point, you'll be randomly assigned to receive either the standard pacing method or the newer physiological pacing method. Neither you nor the doctors assessing your progress will know which type you received, which helps keep the study fair.

After your pacemaker is fitted, you will have regular check-ups, usually every six months. These appointments will involve tests to see how your heart is doing. If you are part of the smaller group looking at heart scans, you'll also have extra ultrasound scans of your heart (echocardiograms) over a two-year period. You can choose whether or not to be part of this extra scan study, even if you join the main study. The study will follow patients for several years.

Potential risks and benefits

Taking part in this study means you will receive a pacemaker, which is a standard procedure with known potential risks, such as infection or issues with the device itself. The main difference is that the type of pacing you receive will be chosen by chance, rather than solely by your doctor. The potential benefit is that one of these pacing methods might be better for your long-term heart health, and by participating, you'll help doctors learn which one that is, benefiting future patients. Regardless of your decision, you will always receive excellent medical care, and you are free to withdraw from the study at any time without affecting your medical treatment.

Locations (45)

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

Beacon Hospital
Verified postcode
Dublin, Ireland· Recruiting
Univerisity Medical Centre Ljubljana
Verified postcode
Ljubljana, Slovenia· Recruiting
Aberdeen Royal Infirmary
Verified postcode
Aberdeen, United Kingdom· Recruiting
Queen's Hospital
Verified postcode
Barking, United Kingdom· Recruiting
Good Hope Hospital
Verified postcode
Birmingham, United Kingdom· Recruiting
Queen Elizabeth Hospital
Verified postcode
Birmingham, United Kingdom· Recruiting
University Hospital Dorset
Verified postcode
Bournemouth, United Kingdom· Recruiting
Royal SUSSEX County Hospital
Verified postcode
Brighton, United Kingdom· Recruiting
Bristol Heart Institute
Verified postcode
Bristol, United Kingdom· Recruiting
Royal Papworth Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
St Richard's Hospital
Verified postcode
Chichester, United Kingdom· Recruiting
University Hospital Coventry
Verified postcode
Coventry, United Kingdom· Recruiting

Common questions

What is bradycardia?

Bradycardia means your heart beats too slowly. A pacemaker helps it beat at a healthy rate.

What's the difference between the two pacing methods?

One is the standard way a pacemaker works, and the other is a newer method designed to mimic your heart's natural electrical system more closely.

Will I know which pacing method I receive?

No, to keep the study fair, neither you nor the doctors assessing you will know which method you've been given.

What is an echocardiogram?

An echocardiogram is a type of ultrasound scan that creates pictures of your heart to show how well it's pumping.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Zachary Whinnett

z.whinnett@imperial.ac.uk +447749576830 Official trial record

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