HIS Bundle PacingNCT06152406
Ablate and Pace HIS Study
A study testing Ablation and Pacemaker Implantation in people with HIS Bundle Pacing and Atrial Fibrillation, run by University Hospitals, Leicester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIS Bundle Pacing, Atrial Fibrillation
- What is being tested?
- Ablation and Pacemaker Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2023to 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
About this study
Official title: 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
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.
Read more
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.
Read the detailed 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.
- Conditions
- HIS Bundle Pacing, Atrial Fibrillation
- Being tested
- Ablation and Pacemaker Implantation
- Keywords
- HIS Bundle Pacing, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation and Pacemaker ImplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Right Ventricular Only Pacing | Active comparator | All study participants will have an RV lead inserted, but this arm will have an RV lead only. Receives: 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. Receives: Procedure: Ablation and Pacemaker Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (6)
Improvement of LV function, LVESV assessed by echocardiogram
Improvement of LV function, LVESV assessed by echocardiogram
Measured: 12 months
Change in NT-ProBNP level
Change in NT-ProBNP level
Measured: 12 months
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
Measured: 12 months
Pacing parameters
RV threshold/HIS bundle lead will be checked, and this will be documented if it has changed.
Measured: 12 months
Fluoroscopy time during the device insertion
Fluoroscopy time during the device insertion
Measured: During device insertion
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start24 Oct 2023
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIS Bundle PacingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152406
- Sponsor's protocol ID
- 153856
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06152406
- Acronym / sponsor ID
- 153856
- Conditions
- HIS Bundle Pacing, Atrial Fibrillation
- Keywords
- HIS Bundle Pacing, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Ventricular Only Pacing | Active comparator | Procedure: Ablation and Pacemaker ImplantationAll study participants will have an RV lead inserted, but this arm will have an RV lead only. |
| HIS Bundle Pacing | Other | Procedure: Ablation and Pacemaker ImplantationParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation and Pacemaker ImplantationAll 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. | Procedure or surgery | HIS Bundle Pacing, Right Ventricular Only Pacing |
Primary outcome
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
Time frame: 12 months
20% improvement in all 3 areas
6 secondary outcomes
Improvement of LV function, LVESV assessed by echocardiogram
Time frame: 12 months
Change in NT-ProBNP level
Time frame: 12 months
Incidence of hospitalisation for heart failure, need for device upgrade to biventricular pacemaker or mortality
Time frame: 12 months
Pacing parameters
Time frame: 12 months
Fluoroscopy time during the device insertion
Time frame: During device insertion
Safety consideration: rate of infection, lead failure, displacement or the need for a repeat procedure
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy
Cardiac Resynchronisation Therapy (CRT), Heart Failure
Recruiting
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Bradycardia, Pacing
Active, not recruiting
Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation
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Recruiting
His-Bundle Corrective Pacing in Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation and Pacemaker Implantation in people with HIS Bundle Pacing and Atrial Fibrillation, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mokhtar Ibrahim, Dr (0116 2583887, mokhtar.ibrahim@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.