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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 or above
Symptomatic AF, New York Heart Association (NYHA) class II-IV
Willing to consent for the study
Impaired LV function, EF <50 %. And or
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ablation and Pacemaker Implantation
Procedure/SurgeryAll 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. All patients will undergo ablation.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with 20% improvement in 6 minutes-walk distance, AFEQT questionnaire score, and number of steps and distance walked per day assessed by a Fitbit smart watch
20% improvement in all 3 areas
Secondary outcomes
Improvement of LV function, LVESV assessed by echocardiogram
Improvement of LV function, LVESV assessed by echocardiogram
Change in NT-ProBNP level
Change in NT-ProBNP level
Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality
Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality
Pacing parameters
RV threshold/HIS bundle lead will be checked, and this will be documented if it has changed.
Sponsors and contacts
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University Hospitals, Leicester
Lead sponsor
Medtronic
Collaborator