Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06152406

Ablate and Pace HIS Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

His Bundle Pacing Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ablation and Pacemaker Implantation

Procedure

All 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.

Primary outcomes

  1. 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

    Time frame: 12 months

    20% improvement in all 3 areas

Secondary outcomes

  1. Improvement of LV function, LVESV assessed by echocardiogram

    Time frame: 12 months

    Improvement of LV function, LVESV assessed by echocardiogram

  2. Change in NT-ProBNP level

    Time frame: 12 months

    Change in NT-ProBNP level

  3. Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality

    Time frame: 12 months

    Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality

  4. Pacing parameters

    Time frame: 12 months

    RV threshold/HIS bundle lead will be checked, and this will be documented if it has changed.

  5. Fluoroscopy time during the device insertion

    Time frame: During device insertion

    Fluoroscopy time during the device insertion

  6. Safety consideration: rate of infection, lead failure, displacement or the need for a repeat procedure

    Time frame: 12 months

    Safety consideration: rate of infection, lead failure, displacement or the need for a repeat procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Mokhtar Ibrahim, Dr

CONTACT

[email protected]

0116 2583887

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Collaborators

  • Medtronic

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 30, 2023
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.