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
- Ablation and Pacemaker Implantation (procedure)
- How long the study runs
- Study runs about 52 months (dates as stated)
- About the drug or intervention
- Ablation and Pacemaker Implantation — procedure: All patients will be implanted with a pacemaker device with one lead positioned in right ventricle (control arm only) and an additional lead will be positioned on the distal (ventricular) HIS bundle if in intervention arm.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 100
- Started
- 2023-10-24
- Last checked
- 2025-12
Plain English Summary
What is this study?
- • Testing a new treatment for his bundle pacing
- • NA - 100 participants
- • Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and estimates suggest its prevalence is increasing
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with his bundle pacing
Where?
- • Leicester - University Hospitals of Leicester NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and estimates suggest its prevalence is increasing. Despite the advances in AF ablation strategies, the outcome of ablation procedures in persistent AF is still unsatisfactory. In addition, many patients are not candidates for ablation due to advanced age, comorbidities and previous failed ablation procedures. It is well known that there is no mortality benefit from rhythm versus rate control strategy in AF, therefore the increased number of AV node ablation and pacemaker insertion for patients with symptomatic AF with uncontrolled heart rate. Following AV node ablation, it is understandable that these patients will be paced 100% of the time where the value of physiological pacing will be at its most. The current standard practice is to pace the right ventricle for this cohort of patients unless they have severe LV systolic dysfunction when a biventricular pacing might be recommended. Previous data showed that RV pacing only can lead to deterioration of LV function, worsening of heart failure symptoms and increased mortality. HIS bundle pacing is a novel technique of pacing through placing the pacemaker lead on the junction box between the top and bottom chamber of the heart. This will allow the utilisation of the normal/intrinsic HIS Purkinjie (eclectic cables) to stimulate the ventricles. This can offer a physiological pacing modality and reduce pacing induced cardiomyopathy specially in pacing dependent pacing. The Ablate and Pace HIS Study proposes that the new method of HIS pacing is safe, effective and superior to the existing method of RV pacing in patients with atrial fibrillation who demonstrate signs of heart failure.
More detail
The Ablate and Pace HIS Study is a single-centre, prospective randomised single-blinded study, recruiting a sub-population of patients with AF who are deemed not fit for rhythm control strategy. These patients have been referred for a pacemaker implant and AVN node ablation as a symptomatic rate control option. The study aims to randomise a total of 100 participants into either the RV only pacing arm or the HBP arm. All patients will be implanted with a pacemaker device with one lead positioned in the right ventricle, and only in the HBP arm will an additional lead be positioned on the distal HIS bundle in order to obtain direct HIS-bundle capture. The RV lead will be only be used as a back-up option for the HBP arm if needed. Participants will undergo AVN ablation either at the same setting or 4-6 weeks later according to clinical indication and operator preference. A double-blinded design will then be employed to investigate the effect of HIS pacing. Endpoint measurements will be taken at Baseline, 4 weeks, 6 months and 12 months post randomisation. Treatment allocation will be blinded to the patients and endpoint assessor. All participants will be informed of their allocated treatment arm at the end of their 12 month follow up visit. Funding has been provided by Medtronic. The study Sponsor is University Hospitals of Leicester.
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 - 100 Years
- Who can join: All genders
What the study is looking for
- ✓Aged 18 or above
- ✓causing symptoms AF, New York Heart Association (NYHA) class II-IV
- ✓Willing to consent for the study
- ✓AF regardless type, deemed not suitable for rhythm control strategy that has been referred for AVN ablation with one...
- ✓Impaired LV function, EF \<50 %. And or
Who cannot take part
- ✗Patient who has already got a pacemaker in situ
- ✗Known severe LVSD when biventricular device is the thought to be the preferred pacing modality
- ✗Females in child bearing period
- ✗Lack of capacity to consent
- ✗Other serious medical condition with life expectancy of less than 1 year
See the full criteria
Where Is This Study? (1 UK site)
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351How to Get in Touch
Mokhtar Ibrahim, Dr
Sponsor contactCONTACT