At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pacemaker - Physiological pacing (device), Pacemaker - Right Ventricular pacing (device)
- How long the study runs
- Study runs about 96 months (dates as stated)
- About the drug or intervention
- Pacemaker - Physiological pacing — device: The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. · Pacemaker - Right Ventricular pacing — device: Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Imperial College London, is called PROTECT-HF. It looks at adults who need a pacemaker because their heartbeat is too slow (bradycardia) or the electrical signals in their heart are not passing properly.
Who can take part
- Adults over 18 whose heart's main pumping chamber is working reasonably well (pumping out more than 35% of its blood with each beat)
- People having a pacemaker fitted for a guideline-based reason, such as a complete heart block, some types of partial heart block, a very slow irregular heartbeat, planned treatment to the heart's electrical node, or certain types of blockage in the heart's wiring
Who may not be able to
- People likely to need only occasional pacing, for example those with sick sinus syndrome alone
- People who are pregnant
- People unable to give informed consent
- People with another illness giving a life expectancy of less than one year
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 2,600
- Started
- 2023-06-05
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for bradycardia
- • NA - 2,600 participants
- • The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with bradycardia
Where?
- • Aberdeen - Aberdeen Royal Infirmary
- • Barking - Queen's Hospital
- • Birmingham - Good Hope Hospital
- • Birmingham - Queen Elizabeth Hospital
- • +39 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients. Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient. Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis. 2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover. 500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).
More detail
Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing. Patients at sites participating in echo sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓1\. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline...
- ✓Permanent or intermittent 3rd degree AV block
- ✓Permanent or intermittent Mobitz type II AV block
- ✓First Degree AV block with a pacing indication
- ✓Slow chronic Atrial Fibrillation or Proposed AV node ablation
Who cannot take part
- ✗Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
- ✗Pregnant women.
- ✗Unable to provide agreement to take part.
- ✗Those with other health condition leading to a life expectancy \<1year.
See the full criteria
Where Is This Study? (43 UK sites)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Queen's Hospital
Barking, United Kingdom
Good Hope Hospital
Birmingham, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital Dorset
Bournemouth, United Kingdom
Royal SUSSEX County Hospital
Brighton, United Kingdom
Bristol Heart Institute
Bristol, United Kingdom
Royal Papworth Hospital
Cambridge, United Kingdom
St Richard's Hospital
Chichester, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Croydon
Croydon, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Victoria Hospital
Fife Keith, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Wycombe Hospital
High Wycombe, United Kingdom
Forth Valley Royal Hospital
Larbert, United Kingdom
Leeds Teaching Hospital
Leeds, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Hammersmith Hospital
London, United Kingdom
Kettering Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Royal Free London/ Barnet Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Watford General Hospital
London, United Kingdom
James Cook Hospital
Middlesbrough, United Kingdom
King's Mill Hospital
Nottingham, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Royal Berkshire
Reading, United Kingdom
East Surrey
Redhill, United Kingdom
Rotherham General Hospital
Rotherham, United Kingdom
Northern General
Sheffield, United Kingdom
Wexham Park Hospital
Slough, United Kingdom
Southampton
Southampton, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Great Western
Swindon, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Torbay Hospital
Torquay, United Kingdom
UHS Worthing
Worthing, United Kingdom
York Hospital
York, United Kingdom
How to Get in Touch
Zachary Whinnett
Sponsor contactCONTACT
Daniel Keene
Sponsor contactCONTACT