Heart Failure, SystolicHEPA-HisNCT04701112
Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure
A study testing Temporary His bundle pacing in people with Heart Failure, Systolic and Left Bundle Branch Block, run by Region Skane at 1 site in Sweden.
Trial summary
Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for patients with low ejection fraction and persistent symptoms of heart failure despite medical therapy and a wide QRS-complex, preferably with a left bundle branch block. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Systolic, Left Bundle Branch Block, Wide QRS Complex
- What is being tested?
- Temporary His bundle pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 27 Feb 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Native QRS-duration >130 ms and a left bundle branch block or previous His-ablation
- Heart failure in New York Heart Association functional class II-IV
- Echocardiographic non-responder to ongoing CRT defined as <15% reduction in LVESV compared to pre-CRT examination
- Clinical non-responder to ongoing CRT, defined as lack of subjective improvement after CRT
- Signed informed consent
Who cannot join
- Known access site problems in vena jugularis interna dx or sin
- Not able to perform supine cycling
- Presence of severe tricuspid regurgitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Hemodynamic Effects of His-bundle Pacing in Bi-Ventricular Pacing Non-responders (The HEPA-His Trial)
Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for patients with low ejection fraction and persistent symptoms of heart failure despite medical therapy and a wide QRS-complex, preferably with a left bundle branch block. Unfortunately, up to 40 % receiving CRT do not respond with subjective improvement or improved left ventricular ejection fraction from the treatment.
There are few therapeutic alternatives in patients not responding to CRT with BVP, and the potential to improve cardiac function in these patients could make a large difference in terms of life quality and prognosis.
Read more
His-bundle pacing (HBP) can be a suitable alternative, but is likely not possible in all patients with failed CRT. Furthermore, upgrading to HBP does require a surgical procedure and therefore exposes the patients to risk of complications (e.g. infection of the device). Therefore, early identification of the patients who are likely to benefit from an upgrade to HBP would be beneficial.
This study aims to evaluate if patients with failed CRT treatment will benefit from hemodynamic improvement if they are treated with temporary HBP, without opening the device-pocket, and exposing the existing pacemaker-device to a risk of infection. A temporary pacemaker lead and pacing sheath will be used, and placed in the heart via a blood vessel on the right side of neck, using local anaesthesia. Acute effects on the pump function of the heart will be measured during rest and during supine bicycle test (the equivalent of moderate physical activity). Factors associated with a beneficial effect will be evaluated on a group basis.
If the individual patient experiences an improvement of cardiac function during the test, he/she will be offered an upgrade to HBP and a replacement of the existing device.
Read the detailed description
Primary hypothesis:
His-bundle pacing will lead to a better stroke volume at rest compared to biventricular pacing.
Primary outcome measure:
Stroke-volume (ml) at rest assessed by invasive hemodynamic measurements with the thermodilution method using a Swan-Ganz catheter.
Recruitment:
Patients will be recruited from the dedicated CRT outpatient clinic at Skane University Hospital. This outpatient clinic evaluates all CRT recipients at 6 months after device implant. If the patient is then a "non-responder" by subjective and objective measures, it is unlikely that there will be any further benefit from the CRT device. Those patients fulfilling the inclusion criteria but not the exclusion criteria will therefore be invited to participate in the study. Written information will be provided to all patients prior to informed consent is signed.
Procedure:
All patients will undergo a temporary His-bundle stimulation and hemodynamic evaluation. The procedure takes place at the dedicated laboratory for advanced hemodynamic evaluation at Skåne University Hospital in Lund. The first option for vascular access is the right external jugular vein. Under sterile conditions, ultrasound guided venous puncture will be performed, using standard Seldinger technique. A 7F catheter (Medtronic C315) will then be placed over a long guidewire, and used to direct a dedicated pacemaker lead (Medtronic Select Secure 3830) to the His bundle. In case of technical difficulties, a steerable 9F catheter will be used instead (Medtronic C304 deflectable). If HBP is not possible using jugular access, an alternate access via the right femoral vein may be used instead. If the femoral vein is used, only resting measurements will be performed, since it is not possible to thread on the supine bike with a catheter in situ via the femoral vein. In parallel, in a short 8F introducer, a 7F multilumen Swan Ganz catheter will be placed over a long guidewire, and advanced to the left or right pulmonary artery. The catheter will then be wedged in a pulmonary segmental artery to obtain left atrial pressure curves.
The pacing lead will be connected to an electrophysiology 12-lead ECG system with capability of pacing and continuous ECG registration of external and intracardiac signals. His bundle potential will be identified probing the correct anatomical area with the electrode, and subsequently the pacing properties of the electrode will be tested. If the pacing properties result in selective (or subsidiary non-selective) his bundle capture, the electrode will be secured in place by 2-3 careful rotations of the entire electrode. The goal is to achieve a stable position with minimal risk of damaging the conduction system by trauma. Since the patients are paced using the CRT device anyway, trauma to the conduction system will not be deleterious, but it may hamper the ability to place a permanent HBP lead at a later stage, if that is indicated. When stable pacing conditions are in place, the stimulation program will be initiated. Depending on randomization results, the intrinsic CRT system or the temporary His-lead will be used for pacing. Pacing and sensing in the right atrium will be achieved using atrial electrodes on the outside of the Swan Ganz catheter.
The patients are randomized to wither Biventricular pacing first or HBP first. The pacing program involves both pacing at rest and pacing during sub maximal exercise test (supine bicycle test). Each pacing step is sustained at steady state for at least 2 minutes prior to measurement of intracardiac pressures, cardiac output and stroke volume calculations. After the pacing protocol is finished, the catheters are withdrawn and the site of venopuncture is manually compressed during 5 minutes. The patients are then observed during 2 hours, before discharge and completion of the study.
A hemodynamic optimization will be performed regarding device settings for all patients. Patients who have a positive hemodynamic response to HBP, compared to CRT pacing, will at a follow-up stage be offered an upgrade to permanent HBP.
- Being tested
- Temporary His bundle pacing
- Keywords
- His Bundle pacing, Cardiac Resynchronization Therapy, Pacemaker
- Medical subject headings
- Heart Failure, Systolic, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary His bundle pacingDevice
Temporary use of a Medtronic 3830 electrode placed in the region of His bundle, in combination with a Medtronic 5392 dual chamber external pacemaker and a temporary Edwards D200F7 Swan Ganz Pacing -catheter with atrial pacing capability.
AV synchronous pacing (DDD 60/minute during rest and 120/minute during exercise, AV delay 150/180ms) will be performed using the atrial port (pacing catheter atrial electrodes) and ventricular port (His bundle electrode), or in the case of atrial fibrillation, only pacing the the His bundle in VVI mode 60/minute during rest and 120/minute during exercise.
The Swan-Ganz will then be used for hemodynamic measurements during pacing. A Cardiotek ECG system will be used for simultaneous 12 lead ECG registration.
| Study group | Role | What they receive |
|---|---|---|
| His-bundle pacing first | Experimental | AV sequential His-bundle pacing (or VVI pacing if in atrial fibrillation) via temporary right atrial and His-bundle electrodes.
Then AV sequential Biventricular pacing via the patient's already implanted CRT device.
Measurements of stroke volume, cardiac output, pressure in the right ventricle and pulmonary capillary wedge pressure, during rest and exercise. Simultaneous 12 lead ECG registration. Receives: Device: Temporary His bundle pacing |
| Biventricular pacing first | Active comparator | AV sequential biventricular pacing (or VVI pacing if in atrial fibrillation) via the patient's already implanted CRT device. Then AV sequential or VVI His-bundle pacing via temporary right atrial and His-bundle electrodes.
Measurements of stroke volume, cardiac output, pressure in the right ventricle and pulmonary capillary wedge pressure, during rest and exercise. Simultaneous 12 lead ECG registration. Receives: Device: Temporary His bundle pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stroke volume (ml) at rest, between Biventricular pacing compared to His bundle pacing
Stroke volume will be measured using the thermodilution method, and paired T-test will be used to evaluate the change in stroke volume between the different pacing modes.
Measured: During procedure
Secondary outcomes (6)
Change in stroke volume (ml) at sub-maximal exercise, between Biventricular pacing compared to His bundle pacing
Stroke volume (ml) measured by the thermodilution method.
Measured: During procedure
Change in Cardiac output (l/min) at rest, between Biventricular pacing compared to His bundle pacing
Cardiac output (l/min) at rest assessed by invasive hemodynamic measurements with the thermodilution method.
Measured: During procedure
Change in cardiac output (l/min) at submaximal exercise, between Biventricular pacing compared to His bundle pacing
Cardiac output (l/min) at sub-maximal exercise assessed by invasive hemodynamic measurements with the thermodilution method using a Swan-Ganz catheter.
Measured: During procedure
Change in stroke work index (mmHg x ml/m2) at rest, between Biventricular pacing compared to His bundle pacing
Calculation of stroke work index based on invasive measurements
Measured: During procedure
Change in stroke work index (mmHg x ml/m2) at sub-maximal exercise, between Biventricular pacing compared to His bundle pacing
Calculation of stroke work index based on invasive measurements
Measured: During procedure
Change in QRS vector area, between Biventricular pacing compared to His bundle pacing
Change in high resolution digital ECG recording of QRS vector area
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Sep 2021
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Why it stopped: Logistic challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar Braun, MD PhD, Principal investigator, Region Skane, Lund UniversityRasmus Borgquist, MD PhD, Principal investigator, Region Skane, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701112
- Sponsor's protocol ID
- Hepa-His trial
- Acronym
- HEPA-His
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 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
- Acute Hemodynamic Effects of His-bundle Pacing in Bi-Ventricular Pacing Non-responders (The HEPA-His Trial)
- ClinicalTrials.gov ID
- NCT04701112
- Acronym / sponsor ID
- HEPA-His / Hepa-His trial
- Keywords
- His Bundle pacing, Cardiac Resynchronization Therapy, Pacemaker
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistic challenges
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 8 Jan 2021 (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.
Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for patients with low ejection fraction and persistent symptoms of heart failure despite medical therapy and a wide QRS-complex, preferably with a left bundle branch block. Unfortunately, up to 40 % receiving CRT do not respond with subjective improvement or improved left ventricular ejection fraction from the treatment.
There are few therapeutic alternatives in patients not responding to CRT with BVP, and the potential to improve cardiac function in these patients could make a large difference in terms of life quality and prognosis.
His-bundle pacing (HBP) can be a suitable alternative, but is likely not possible in all patients with failed CRT. Furthermore, upgrading to HBP does require a surgical procedure and therefore exposes the patients to risk of complications (e.g. infection of the device). Therefore, early identification of the patients who are likely to benefit from an upgrade to HBP would be beneficial.
This study aims to evaluate if patients with failed CRT treatment will benefit from hemodynamic improvement if they are treated with temporary HBP, without opening the device-pocket, and exposing the existing pacemaker-device to a risk of infection. A temporary pacemaker lead and pacing sheath will be used, and placed in the heart via a blood vessel on the right side of neck, using local anaesthesia. Acute effects on the pump function of the heart will be measured during rest and during supine bicycle test (the equivalent of moderate physical activity). Factors associated with a beneficial effect will be evaluated on a group basis.
If the individual patient experiences an improvement of cardiac function during the test, he/she will be offered an upgrade to HBP and a replacement of the existing device.
Detailed description
Primary hypothesis:
His-bundle pacing will lead to a better stroke volume at rest compared to biventricular pacing.
Primary outcome measure:
Stroke-volume (ml) at rest assessed by invasive hemodynamic measurements with the thermodilution method using a Swan-Ganz catheter.
Recruitment:
Patients will be recruited from the dedicated CRT outpatient clinic at Skane University Hospital. This outpatient clinic evaluates all CRT recipients at 6 months after device implant. If the patient is then a "non-responder" by subjective and objective measures, it is unlikely that there will be any further benefit from the CRT device. Those patients fulfilling the inclusion criteria but not the exclusion criteria will therefore be invited to participate in the study. Written information will be provided to all patients prior to informed consent is signed.
Procedure:
All patients will undergo a temporary His-bundle stimulation and hemodynamic evaluation. The procedure takes place at the dedicated laboratory for advanced hemodynamic evaluation at Skåne University Hospital in Lund. The first option for vascular access is the right external jugular vein. Under sterile conditions, ultrasound guided venous puncture will be performed, using standard Seldinger technique. A 7F catheter (Medtronic C315) will then be placed over a long guidewire, and used to direct a dedicated pacemaker lead (Medtronic Select Secure 3830) to the His bundle. In case of technical difficulties, a steerable 9F catheter will be used instead (Medtronic C304 deflectable). If HBP is not possible using jugular access, an alternate access via the right femoral vein may be used instead. If the femoral vein is used, only resting measurements will be performed, since it is not possible to thread on the supine bike with a catheter in situ via the femoral vein. In parallel, in a short 8F introducer, a 7F multilumen Swan Ganz catheter will be placed over a long guidewire, and advanced to the left or right pulmonary artery. The catheter will then be wedged in a pulmonary segmental artery to obtain left atrial pressure curves.
The pacing lead will be connected to an electrophysiology 12-lead ECG system with capability of pacing and continuous ECG registration of external and intracardiac signals. His bundle potential will be identified probing the correct anatomical area with the electrode, and subsequently the pacing properties of the electrode will be tested. If the pacing properties result in selective (or subsidiary non-selective) his bundle capture, the electrode will be secured in place by 2-3 careful rotations of the entire electrode. The goal is to achieve a stable position with minimal risk of damaging the conduction system by trauma. Since the patients are paced using the CRT device anyway, trauma to the conduction system will not be deleterious, but it may hamper the ability to place a permanent HBP lead at a later stage, if that is indicated. When stable pacing conditions are in place, the stimulation program will be initiated. Depending on randomization results, the intrinsic CRT system or the temporary His-lead will be used for pacing. Pacing and sensing in the right atrium will be achieved using atrial electrodes on the outside of the Swan Ganz catheter.
The patients are randomized to wither Biventricular pacing first or HBP first. The pacing program involves both pacing at rest and pacing during sub maximal exercise test (supine bicycle test). Each pacing step is sustained at steady state for at least 2 minutes prior to measurement of intracardiac pressures, cardiac output and stroke volume calculations. After the pacing protocol is finished, the catheters are withdrawn and the site of venopuncture is manually compressed during 5 minutes. The patients are then observed during 2 hours, before discharge and completion of the study.
A hemodynamic optimization will be performed regarding device settings for all patients. Patients who have a positive hemodynamic response to HBP, compared to CRT pacing, will at a follow-up stage be offered an upgrade to permanent HBP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| His-bundle pacing first | Experimental | Device: Temporary His bundle pacingAV sequential His-bundle pacing (or VVI pacing if in atrial fibrillation) via temporary right atrial and His-bundle electrodes. Then AV sequential Biventricular pacing via the patient's already implanted CRT device. Measurements of stroke volume, cardiac output, pressure in the right ventricle and pulmonary capillary wedge pressure, during rest and exercise. Simultaneous 12 lead ECG registration. |
| Biventricular pacing first | Active comparator | Device: Temporary His bundle pacingAV sequential biventricular pacing (or VVI pacing if in atrial fibrillation) via the patient's already implanted CRT device. Then AV sequential or VVI His-bundle pacing via temporary right atrial and His-bundle electrodes. Measurements of stroke volume, cardiac output, pressure in the right ventricle and pulmonary capillary wedge pressure, during rest and exercise. Simultaneous 12 lead ECG registration. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years
- Native QRS-duration >130 ms and a left bundle branch block or previous His-ablation
- Heart failure in New York Heart Association functional class II-IV
- Echocardiographic non-responder to ongoing CRT defined as <15% reduction in LVESV compared to pre-CRT examination
- Clinical non-responder to ongoing CRT, defined as lack of subjective improvement after CRT
Key exclusion criteria (3 listed)
- Known access site problems in vena jugularis interna dx or sin
- Not able to perform supine cycling
- Presence of severe tricuspid regurgitation
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 |
|---|---|---|
| Temporary His bundle pacingTemporary use of a Medtronic 3830 electrode placed in the region of His bundle, in combination with a Medtronic 5392 dual chamber external pacemaker and a temporary Edwards D200F7 Swan Ganz Pacing -catheter with atrial pacing capability. AV synchronous pacing (DDD 60/minute during rest and 120/minute during exercise, AV delay 150/180ms) will be performed using the atrial port (pacing catheter atrial electrodes) and ventricular port (His bundle electrode), or in the case of atrial fibrillation, only pacing the the His bundle in VVI mode 60/minute during rest and 120/minute during exercise. The Swan-Ganz will then be used for hemodynamic measurements during pacing. A Cardiotek ECG system will be used for simultaneous 12 lead ECG registration. | Device | Biventricular pacing first, His-bundle pacing first |
Primary outcome
Change in stroke volume (ml) at rest, between Biventricular pacing compared to His bundle pacing
Time frame: During procedure
Stroke volume will be measured using the thermodilution method, and paired T-test will be used to evaluate the change in stroke volume between the different pacing modes.
6 secondary outcomes
Change in stroke volume (ml) at sub-maximal exercise, between Biventricular pacing compared to His bundle pacing
Time frame: During procedure
Change in Cardiac output (l/min) at rest, between Biventricular pacing compared to His bundle pacing
Time frame: During procedure
Change in cardiac output (l/min) at submaximal exercise, between Biventricular pacing compared to His bundle pacing
Time frame: During procedure
Change in stroke work index (mmHg x ml/m2) at rest, between Biventricular pacing compared to His bundle pacing
Time frame: During procedure
Change in stroke work index (mmHg x ml/m2) at sub-maximal exercise, between Biventricular pacing compared to His bundle pacing
Time frame: During procedure
Change in QRS vector area, between Biventricular pacing compared to His bundle pacing
Time frame: During procedure
Results and safety
The study was stopped early (reason given: Logistic challenges). 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.
Oscar Braun, MD PhD principal investigator
Region Skane, Lund University
Rasmus Borgquist, MD PhD principal investigator
Region Skane, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary His bundle pacing in people with Heart Failure, Systolic and Left Bundle Branch Block, run by Region Skane at 1 site 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 6 inclusion and 3 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: stopped early, 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 1 site 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?
The study was stopped early (reason given: Logistic challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stroke volume (ml) at rest, between Biventricular pacing compared to His bundle pacing (time frame: During procedure). 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.