Pacing-Induced CardiomyopathyNCT04739553
His Pacing Feasibility and Cardiac Electrical Activation
A study testing His Pacing in people with Pacing-Induced Cardiomyopathy and AV Block, run by Aalborg University Hospital.
Trial summary
This study will examine the clinical feasibility of His pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. Secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and His pacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacing-Induced Cardiomyopathy, AV Block, Heart Failure
- What is being tested?
- His Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2021to Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Permanent pacemaker indication with expected high demand of right ventricular pacing (>40%) and left ventricular ejection fraction >40%.
Who cannot join
- No class I indication for CRT pacemaker (HRS 2018 Pacing Guidelines)
- Hemodynamically unstable patients
- Severely reduced kidney function
- Former serious adverse reactions to contrast media
- Pregnant or lactating
- Severe psychiatric disorder which can compromise compliance with protocol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation
This study will examine the clinical feasibility of His pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. Secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and His pacing.
Read the detailed description
After being informed about the study and potential risks, all eligible patients giving written consent will be included. The study is a clinical single-center interventional study. The patients (n = 25) need to have an expected high demand for ventricular pacing and no established class I indication for cardiac resynchronization therapy. They will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port. Postoperatively, the baseline examinations will include: transthoracic echocardiography, 12-lead ECG with a 3D photography of the chest wall to document ECG electrode location, and a contrast-enhanced cardiac CT scan. The echocardiography and ECG will be performed during traditional right ventricular pacing only and His pacing only. His pacing will be used as the permanent programming of choice if feasible during follow up. The CT scan is used for documenting the final positions of the pacing leads and to create a patient-specific 3D model of the cardiac electrical activation using a software which enables merging of a CT scan and ECG and a CT chest photography. During follow up (1-3 and 12 months), transthoracic echocardiography, 12-lead ECG and 3D chest photography are repeated for assessment of mechanical and electrical function during pacing. The performance of all implanted pacing lead will be evaluated at each follow up visit.
- Conditions
- Pacing-Induced Cardiomyopathy, AV Block, Heart Failure
- Being tested
- His Pacing
- Medical subject headings
- Atrioventricular Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
His PacingDevice
The patients will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port.
| Study group | Role | What they receive |
|---|---|---|
| His Pacing | Experimental | Implant of a supplementary His pacing lead in addition to a traditional RV pacing lead. Receives: Device: His Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of chronic His pacing success
Chronic His capture with clinically acceptable pacing threshold (<=3.5V)
Measured: Evaluated at 1 year follow up
Secondary outcomes (4)
Rate of perioperative His pacing success
Perioperative his capture with clinically acceptable pacing threshold (<=3.5V)
Measured: The implant procedure duration i.e. incision to skin closure
QRS duration (ms)
Comparing His pacing and RV pacing
Measured: Implantation to 1 year follow up
Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters
Comparing left ventricular mechanical dyssynchrony during His pacing and RV pacing using echocardiographic two-dimensional longitudinal strain
Measured: Implant to 1 year follow up
Changes in regional right and left ventricular electrical activation delay
Comparing electrical activation pattern during His pacing and RV pacing using non-invasive electroanatomical mapping. This is achieved using software that merges data from a 12-lead electrocardiogram (ECG), chest wall three-dimensional picture of ECG lead positions, and a cardiac computed tomography scan.
Measured: Implant to 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start15 Feb 2021 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacing-Induced CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Margrethe Thoegersen, Aalborg University Hospital
- Investigators
- Sam Riahi, MD PhD, Study director, Aalborg University HospitalPeter Søgaard, MD DMSc, Study director, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739553
- Sponsor's protocol ID
- N-20200032
- Status last verified
- Feb 2021
- First submitted
- 19 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation
- ClinicalTrials.gov ID
- NCT04739553
- Acronym / sponsor ID
- N-20200032
- Conditions
- Pacing-Induced Cardiomyopathy, AV Block, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 Feb 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.
This study will examine the clinical feasibility of His pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. Secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and His pacing.
Detailed description
After being informed about the study and potential risks, all eligible patients giving written consent will be included. The study is a clinical single-center interventional study. The patients (n = 25) need to have an expected high demand for ventricular pacing and no established class I indication for cardiac resynchronization therapy. They will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port. Postoperatively, the baseline examinations will include: transthoracic echocardiography, 12-lead ECG with a 3D photography of the chest wall to document ECG electrode location, and a contrast-enhanced cardiac CT scan. The echocardiography and ECG will be performed during traditional right ventricular pacing only and His pacing only. His pacing will be used as the permanent programming of choice if feasible during follow up. The CT scan is used for documenting the final positions of the pacing leads and to create a patient-specific 3D model of the cardiac electrical activation using a software which enables merging of a CT scan and ECG and a CT chest photography. During follow up (1-3 and 12 months), transthoracic echocardiography, 12-lead ECG and 3D chest photography are repeated for assessment of mechanical and electrical function during pacing. The performance of all implanted pacing lead will be evaluated at each follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| His Pacing | Experimental | Device: His PacingImplant of a supplementary His pacing lead in addition to a traditional RV pacing lead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Permanent pacemaker indication with expected high demand of right ventricular pacing (>40%) and left ventricular ejection fraction >40%.
Key exclusion criteria (6 listed)
- No class I indication for CRT pacemaker (HRS 2018 Pacing Guidelines)
- Hemodynamically unstable patients
- Severely reduced kidney function
- Former serious adverse reactions to contrast media
- Pregnant or lactating
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 PacingThe patients will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port. | Device | His Pacing |
Primary outcome
Rate of chronic His pacing success
Time frame: Evaluated at 1 year follow up
Chronic His capture with clinically acceptable pacing threshold (<=3.5V)
4 secondary outcomes
Rate of perioperative His pacing success
Time frame: The implant procedure duration i.e. incision to skin closure
QRS duration (ms)
Time frame: Implantation to 1 year follow up
Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters
Time frame: Implant to 1 year follow up
Changes in regional right and left ventricular electrical activation delay
Time frame: Implant to 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation
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Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
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Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture
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Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
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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.
Sam Riahi, MD PhD study director
Aalborg University Hospital
Peter Søgaard, MD DMSc study director
Aalborg University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing His Pacing in people with Pacing-Induced Cardiomyopathy and AV Block, run by Aalborg University Hospital.
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 1 inclusion and 6 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Anna M Thøgersen, MD DMSc (+4597664427, anmat@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of chronic His pacing success (time frame: Evaluated at 1 year follow up). 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 4 Feb 2021.