Ablate and Pace HIS Study
Recruiting · NCT06152406 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospitals, Leicester
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- Less than 18 years
- Unwilling to consent for the study
Where it is running
1 location listed.
- University Hospitals of Leicester NHS Trust - Leicester, Leicestershire, United Kingdom