Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-10-24
2028-02-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Right Ventricular Only Pacing
All study participants will have an RV lead inserted, but this arm will have an RV lead only.
Ablation 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.
HIS Bundle Pacing
Participants in this group will have HIS bundle pacing, but in addition will have an RV lead inserted that will serve as a backup alternative in the event HIS bundle pacing is not effective.
Ablation 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.
Interventions
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Ablation 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
Medtronic
INDUSTRY
Responsible Party
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Locations
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University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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153856
Identifier Type: -
Identifier Source: org_study_id
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