Comparing two pacing methods for treating slow heart rates
Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment
NA · Imperial College London · NCT05815745
This study is testing two different ways to help people with slow heart rates feel better by comparing traditional pacing to a newer method in 2600 patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 45 sites (Dublin and 44 other locations) |
| Trial ID | NCT05815745 on ClinicalTrials.gov |
What this trial studies
The PROTECT-HF trial is a multi-centre randomized controlled trial designed to compare two different pacing approaches for patients with bradycardia. It will evaluate the traditional right ventricular pacing against a newer physiological pacing method, which includes His and Left bundle area pacing, in a cohort of 2600 patients. Participants will be randomly assigned to one of the two pacing methods, and their outcomes will be assessed at baseline and every six months thereafter. The study aims to provide insights into the effectiveness of these pacing strategies in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with specific pacing indications and a left ventricular ejection fraction greater than 35%.
Not a fit: Patients who only require occasional ventricular pacing or have a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pacing strategies that enhance heart function and quality of life for patients with bradycardia.
How similar studies have performed: Previous studies have explored various pacing methods, but this specific comparison of physiological pacing versus right ventricular pacing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
We will recruit patients who are referred for clinically indicated pacemaker implantation Inclusion Criteria: 1\. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline based ventricular pacing indications: 1. Permanent or intermittent 3rd degree AV block 2. Permanent or intermittent Mobitz type II AV block 3. First Degree AV block with a pacing indication 4. Slow chronic Atrial Fibrillation or Proposed AV node ablation 5. Bifascicular block with a pacing indication 6. Trifascicular block with a pacing indication 7. Wenckebach with a pacing indication Exclusion Criteria: 1. Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome. 2. Pregnant women. 3. Unable to provide informed consent. 4. Those with comorbidity leading to a life expectancy \<1year.
Where this trial is running
Dublin and 44 other locations
- Beacon Hospital — Dublin, Ireland (RECRUITING)
- Univerisity Medical Centre Ljubljana — Ljubljana, Slovenia (RECRUITING)
- Aberdeen Royal Infirmary — Aberdeen, United Kingdom (RECRUITING)
- Queen's Hospital — Barking, United Kingdom (RECRUITING)
- Good Hope Hospital — Birmingham, United Kingdom (RECRUITING)
- Queen Elizabeth Hospital — Birmingham, United Kingdom (RECRUITING)
- University Hospital Dorset — Bournemouth, United Kingdom (RECRUITING)
- Royal SUSSEX County Hospital — Brighton, United Kingdom (RECRUITING)
- Bristol Heart Institute — Bristol, United Kingdom (RECRUITING)
- Royal Papworth Hospital — Cambridge, United Kingdom (RECRUITING)
- St Richard's Hospital — Chichester, United Kingdom (RECRUITING)
- University Hospital Coventry — Coventry, United Kingdom (RECRUITING)
- Croydon — Croydon, United Kingdom (RECRUITING)
- Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (RECRUITING)
- Victoria Hospital — Fife Keith, United Kingdom (RECRUITING)
- Medway Maritime Hospital — Gillingham, United Kingdom (RECRUITING)
- Wycombe Hospital — High Wycombe, United Kingdom (RECRUITING)
- Forth Valley Royal Hospital — Larbert, United Kingdom (RECRUITING)
- Leeds Teaching Hospital — Leeds, United Kingdom (RECRUITING)
- Glenfield Hospital — Leicester, United Kingdom (RECRUITING)
- Liverpool Heart and Chest Hospital — Liverpool, United Kingdom (RECRUITING)
- Hammersmith Hospital — London, United Kingdom (RECRUITING)
- Kettering Hospital — London, United Kingdom (RECRUITING)
- King's College Hospital — London, United Kingdom (RECRUITING)
- Royal Free London/ Barnet Hospital — London, United Kingdom (RECRUITING)
- St Bartholomew's Hospital — London, United Kingdom (RECRUITING)
- Watford General Hospital — London, United Kingdom (RECRUITING)
- James Cook Hospital — Middlesbrough, United Kingdom (RECRUITING)
- King's Mill Hospital — Nottingham, United Kingdom (RECRUITING)
- Nottingham City Hospital — Nottingham, United Kingdom (RECRUITING)
- John Radcliffe Hospital — Oxford, United Kingdom (RECRUITING)
- Derriford Hospital — Plymouth, United Kingdom (RECRUITING)
- Queen Alexandra Hospital — Portsmouth, United Kingdom (RECRUITING)
- Royal Berkshire — Reading, United Kingdom (RECRUITING)
- East Surrey — Redhill, United Kingdom (RECRUITING)
- Rotherham General Hospital — Rotherham, United Kingdom (RECRUITING)
- Northern General — Sheffield, United Kingdom (RECRUITING)
- Wexham Park Hospital — Slough, United Kingdom (RECRUITING)
- Southampton — Southampton, United Kingdom (RECRUITING)
- Morriston Hospital — Swansea, United Kingdom (RECRUITING)
- Great Western — Swindon, United Kingdom (RECRUITING)
- Musgrove Park Hospital — Taunton, United Kingdom (RECRUITING)
- Torbay Hospital — Torquay, United Kingdom (RECRUITING)
- UHS Worthing — Worthing, United Kingdom (RECRUITING)
- York Hospital — York, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Zachary Whinnett
- Email: z.whinnett@imperial.ac.uk
- Phone: +447749576830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bradycardia, Pacing, Right Ventricular Pacing, His Bundle Pacing, Left Bundle Branch Area Pacing