RecruitingNot ApplicableNCT06152406

Ablate and Pace HIS Study

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


Sponsor

University Hospitals, Leicester

Enrollment

100 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial (Ablate and Pace HIS Study) is comparing two ways of controlling heart rate in people with atrial fibrillation (AF) who need a procedure called AV node ablation (which permanently slows the electrical signals causing the irregular heartbeat). The study compares the standard approach (right ventricular pacing) with a newer technique called His-Purkinje system pacing, which mimics the heart's natural electrical pathway more closely. **You may be eligible if...** - You are 18 years or older - You have symptomatic atrial fibrillation (any type) with significant heart failure symptoms (NYHA class II–IV) - Your doctor has determined you are not a good candidate for rhythm control therapy - You have either a weakened heart pump (EF below 50%) or elevated heart failure markers in your blood (NT-ProBNP > 365 ng/L) **You may NOT be eligible if...** - You already have a pacemaker - You are known to have severely reduced heart function where a biventricular (both ventricle) device is preferred - You are a woman of childbearing age - You lack the mental capacity to give consent - You have another serious illness with less than 1 year life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAblation and Pacemaker Implantation

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.


Locations(1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

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NCT06152406


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