Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT06152406

Ablate and Pace HIS Study

Led by University Hospitals, Leicester · Updated on 2026-01-05

100

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

Sponsors

U

University Hospitals, Leicester

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Ablate and Pace HIS Study

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 or above
  • Symptomatic atrial fibrillation with New York Heart Association (NYHA) class II-IV
  • Willing to consent for the study
  • Atrial fibrillation regardless of type, deemed not suitable for rhythm control strategy and referred for AV node ablation with either impaired left ventricular function (ejection fraction less than 50%) or raised N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) greater than 365 ng/L
Not Eligible

You will not qualify if you...

  • Already have a pacemaker implanted
  • Known severe left ventricular systolic dysfunction when biventricular pacing is preferred
  • Female in childbearing period
  • Lack capacity to consent
  • Serious medical condition with life expectancy less than 1 year
  • Under 18 years old
  • Unwilling to consent for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom, LE1 5WW

Actively Recruiting

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Research Team

M

Mokhtar Ibrahim, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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