NCT06152406Recruiting
Ablate and Pace HIS Study
Safety and Efficacy of Distal His Bundle Pacing Compared to Right Ventricular Pacing in Patients With Symptomatic Atrial Fibrillation Undergoing AV Node Ablation With Evidence of Heart Failure, a Randomised Control Study
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 21 Sept 2023
- Start date
- 24 Oct 2023
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- University Hospitals, Leicester
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06152406
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 24 Oct 2023 to the primary completion date, 29 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other serious medical condition with life expectancy of less than 1 year
Other
- 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
- Less than 18 years
- Unwilling to consent for the study
Who the study is looking for
- Aged 18 or above
- Symptomatic 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 of the following:
- Impaired LV function, EF \<50 %. And or
- Raised N-Terminal Pro B-type Natriuretic Peptide ( NT-ProBNP) \>365 ng/L
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.