His Bundle PacingHIS-PrEFNCT04529577
His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection Fraction
A study testing His-bundle pacing in people with His Bundle Pacing and Heart Failure, Systolic, run by Region Skane at 3 sites in Sweden.
Trial summary
The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- His Bundle Pacing, Heart Failure, Systolic
- What is being tested?
- His-bundle pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- AV block II or III with high expected pacing need
- Left ventricular ejection fraction between 40% and 55% (inclusive)
- Willing to participate and sign informed consent
Who cannot join
- Under 18 years old
- Pregnant
- Hypertrophic cardiomyopathy
- Cardiac sarcoidosis
- Cardiac amyloidosis
- Previous myocardial infarction within last 3 months
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- Ventricular septum defect or other other left ventricular corrective surgery
- Congenital heart disease surgically corrected
- Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Recruiting
Skane University Hospital
Lund
Rasmus Borgquist, +4646171000, rasmus.borgquist@med.lu.se
- Recruiting
Norrland University Hospital
Umeå
Steen Jensen, MD PhD, steen.jensen@medicin.umu.se
- Recruiting
Region Hallands Sjukhus Varberg
Varberg
Cecilia Rorsman, Cecilia.Rorsman@regionhalland.se
About this study
Official title: His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection
The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.
Read the detailed description
Patients with reduced systolic ejection fraction (40≤ ejection fraction ≤55%) and pacemaker indication due to high degree AV block are included. The study has a randomized double blinded crossover design. Patients are implanted with a standard right ventricle lead and right atrial lead (if indicated), and in addition a His-bundle lead. Randomization is performed as to which pacing modality is used during the first 6 months. After 6 months the pacing modality is changed. Patients are blinded and endpoint adjudicators, including echocardiography staff, are blinded. Device nurse and physician are not blinded.
Primary endpoint is difference in left ventricular ejection fraction after 6 months, paired comparisons are used and each patient is their own control. Secondary endpoints include complications and safety of the device/electrode, and quality of life.
- Conditions
- His Bundle Pacing, Heart Failure, Systolic
- Being tested
- His-bundle pacing
- Keywords
- His bundle pacing, Conduction system pacing, Heart failure, systolic, Quality of life, Left ventricular ejection fraction
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
His-bundle pacingDevice
A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated).
A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup.
| Study group | Role | What they receive |
|---|---|---|
| His-bundle pacing first | Experimental | Patients are allocated to receive His-bundle pacing for a period of 6 months. Then the patients will cross over to traditional right ventricular (RV) apical pacing for 6 months. Receives: Device: His-bundle pacing |
| RV apical pacing first | Experimental | Patients are allocated to receive traditional RV apical pacing for a period of 6 months. Then the patients will cross over to His-bundle pacing for 6 months. Receives: Device: His-bundle pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection Fraction
Absolute difference in left ventricular systolic ejection fraction (absolute percent)
Measured: 6 months
Secondary outcomes (8)
Adverse events
Percentage of device-related adverse events. Events will be classified as general, associated with His-bundle lead or associated with RV lead
Measured: 12 months
Left ventricular activation time
Total left ventricular mechanical activation time (measured with tissue doppler echocardiography)
Measured: 6 months
NT-ProBNP
Difference in NT-ProBNP levels
Measured: 6 months
QRS duration
Difference in total QRS duration on ECG
Measured: 6 months
Left Ventricular Activation Time (LVAT)
Maximum unipolar spike-to-peak-T-wave in V5-V6
Measured: 6 months
6 minute walk test
Difference in six minute hall walk test (meters)
Measured: 6 months
Change in quality of life measured by the Short Form Health Survey (SF-36) mean score
Difference in health related quality of life, measured by the SF-36 questionnaire, calculated as difference in mean from baseline to follow-up (calculated using the official scoring algorithm, where each sub scale is assigned a score between 0-100, higher score represents better health)
Measured: 6 months
Change in quality of life measured by the EuroQol EQ-5D-5L Questionnaire
Difference in health related quality of life, measured by the mean score of the EQ-5D (version 5L) questionnaire (totalt score ranging from 5-25 points, higher score represents more health related problems/disability)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (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
- Crossover
- Model description
- Randomized double blinded crossover design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rasmus Borgquist, MD PhD, Principal investigator, Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529577
- Sponsor's protocol ID
- HIS-PrEF_study
- Acronym
- HIS-PrEF
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2020
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- His-bundle Pacing vs. Right Ventricular Apical Pacing in Patients With Reduced Ejection
- ClinicalTrials.gov ID
- NCT04529577
- Acronym / sponsor ID
- HIS-PrEF / HIS-PrEF_study
- Conditions
- His Bundle Pacing, Heart Failure, Systolic
- Keywords
- His bundle pacing, Conduction system pacing, Heart failure, systolic, Quality of life, Left ventricular ejection fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Aug 2020 (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.
The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.
Detailed description
Patients with reduced systolic ejection fraction (40≤ ejection fraction ≤55%) and pacemaker indication due to high degree AV block are included. The study has a randomized double blinded crossover design. Patients are implanted with a standard right ventricle lead and right atrial lead (if indicated), and in addition a His-bundle lead. Randomization is performed as to which pacing modality is used during the first 6 months. After 6 months the pacing modality is changed. Patients are blinded and endpoint adjudicators, including echocardiography staff, are blinded. Device nurse and physician are not blinded.
Primary endpoint is difference in left ventricular ejection fraction after 6 months, paired comparisons are used and each patient is their own control. Secondary endpoints include complications and safety of the device/electrode, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blinded crossover design.
| Arm | Type | Receives |
|---|---|---|
| His-bundle pacing first | Experimental | Device: His-bundle pacingPatients are allocated to receive His-bundle pacing for a period of 6 months. Then the patients will cross over to traditional right ventricular (RV) apical pacing for 6 months. |
| RV apical pacing first | Experimental | Device: His-bundle pacingPatients are allocated to receive traditional RV apical pacing for a period of 6 months. Then the patients will cross over to His-bundle pacing for 6 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AV block II or III with high expected pacing need
- Left ventricular ejection fraction between 40% and 55% (inclusive)
- Willing to participate and sign informed consent
Key exclusion criteria (9 listed)
- Under 18 years old
- Pregnant
- Hypertrophic cardiomyopathy
- Cardiac sarcoidosis
- Cardiac amyloidosis
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 |
|---|---|---|
| His-bundle pacingA standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated). A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup. | Device | His-bundle pacing first, RV apical pacing first |
Primary outcome
Ejection Fraction
Time frame: 6 months
Absolute difference in left ventricular systolic ejection fraction (absolute percent)
8 secondary outcomes
Adverse events
Time frame: 12 months
Left ventricular activation time
Time frame: 6 months
NT-ProBNP
Time frame: 6 months
QRS duration
Time frame: 6 months
Left Ventricular Activation Time (LVAT)
Time frame: 6 months
6 minute walk test
Time frame: 6 months
Change in quality of life measured by the Short Form Health Survey (SF-36) mean score
Time frame: 6 months
Change in quality of life measured by the EuroQol EQ-5D-5L Questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rasmus Borgquist, MD PhD principal investigator
Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing His-bundle pacing in people with His Bundle Pacing and Heart Failure, Systolic, run by Region Skane at 3 sites in Sweden.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maiwand Farouq, MD, PhD (+ 46 40 336415, maiwand.farouq@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection Fraction (time frame: 6 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 28 Feb 2025.