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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06152406
Other study ID # 153856
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 24, 2023
Est. completion date September 2026

Study information

Verified date November 2023
Source University Hospitals, Leicester
Contact Mokhtar Ibrahim, Dr
Phone 0116 2583887
Email mokhtar.ibrahim@uhl-tr.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
United Kingdom University Hospitals of Leicester NHS Trust Leicester Leicestershire

Sponsors (2)

Lead Sponsor Collaborator
University Hospitals, Leicester Medtronic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 20% improvement in all 3 areas 12 months
Secondary Improvement of LV function, LVESV assessed by echocardiogram Improvement of LV function, LVESV assessed by echocardiogram 12 months
Secondary Change in NT-ProBNP level Change in NT-ProBNP level 12 months
Secondary Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality 12 months
Secondary Pacing parameters RV threshold/HIS bundle lead will be checked, and this will be documented if it has changed. 12 months
Secondary Fluoroscopy time during the device insertion Fluoroscopy time during the device insertion During device insertion
Secondary Safety consideration: rate of infection, lead failure, displacement or the need for a repeat procedure Safety consideration: rate of infection, lead failure, displacement or the need for a repeat procedure 12 months
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