Ablate and Pace HIS Study

NCT06152406 | Recruiting

• 1 other identifier: 153856
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIS Bundle Pacing; Atrial Fibrillation

Keywords

HIS Bundle Pacing; Atrial Fibrillation

Outcome Measures

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

  20% improvement in all 3 areas

  12 months

Secondary Outcomes (6)

• Improvement of LV function, LVESV assessed by echocardiogram

  12 months

• Change in NT-ProBNP level

  12 months

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

  12 months

• Pacing parameters

  12 months

• Fluoroscopy time during the device insertion

  During device insertion

Study Arms (2)

Right Ventricular Only Pacing

ACTIVE COMPARATOR

All study participants will have an RV lead inserted, but this arm will have an RV lead only.

Procedure: Ablation and Pacemaker Implantation

HIS Bundle Pacing

OTHER

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.

Procedure: Ablation and Pacemaker Implantation

Interventions

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.

HIS Bundle Pacing; Right Ventricular Only Pacing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• Medtronic: collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mokhtar Ibrahim, Dr

CONTACT

0116 2583887; mokhtar.ibrahim@uhl-tr.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: November 30, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

GB (1)