Actively Recruiting
Ablate and Pace HIS Study
Led by University Hospitals, Leicester · Updated on 2026-01-05
100
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
Sponsors
U
University Hospitals, Leicester
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ablate and Pace HIS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or above
- Symptomatic atrial fibrillation with New York Heart Association (NYHA) class II-IV
- Willing to consent for the study
- Atrial fibrillation regardless of type, deemed not suitable for rhythm control strategy and referred for AV node ablation with either impaired left ventricular function (ejection fraction less than 50%) or raised N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) greater than 365 ng/L
You will not qualify if you...
- Already have a pacemaker implanted
- Known severe left ventricular systolic dysfunction when biventricular pacing is preferred
- Female in childbearing period
- Lack capacity to consent
- Serious medical condition with life expectancy less than 1 year
- Under 18 years old
- Unwilling to consent for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE1 5WW
Actively Recruiting
Research Team
M
Mokhtar Ibrahim, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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