Clinical trial NCT06152406: Ablate and Pace HIS Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIS Bundle Pacing
Atrial Fibrillation
Keywords: HIS Bundle Pacing
Atrial Fibrillation
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

  1. Impaired LV function, EF \<50 %. And or
  2. 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of LV function, LVESV assessed by echocardiogram
timeFrame: 12 months
measure: Change in NT-ProBNP level
timeFrame: 12 months
measure: Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality
timeFrame: 12 months
measure: Pacing parameters
timeFrame: 12 months
measure: Fluoroscopy time during the device insertion
timeFrame: During device insertion
measure: Safety consideration: rate of infection, lead failure, displacement or the need for a repeat procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
Study officials:
References: