Heart FailureHARMONYNCT06843135
Synchrony in Cardiac Conduction: Assessing the Effects of Pacing on Cardiac Performance Through Magnetic Resonance Imaging and Advanced ECG-imaging
A study testing Ventricular pacing in people with Heart Failure and AV Block, run by Amsterdam UMC, location VUmc.
Trial summary
Rationale Right ventricular pacing (RVP) is an established and effective therapy for patients with atrioventricular (AV) block. However, frequent RVP has been associated with left ventricular (LV) dyssynchrony and may progess heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, AV Block
- What is being tested?
- Ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age ≥ 18 years
- Patients with a left ventricular ejection fraction of ≥35%
- Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >20% including:
- Third degree AV block
- Symptomatic or asymptomatic second-degree AV block
- High degree AV block
- Pace and ablate (AV-node ablation)
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- CRT indication (patients with heart failure (NYHA >1) in sinus rhythm with left ventricular ejection fraction (LVEF) <35%, QRS duration >150 ms, and left bundle branch block (LBBB) QRS morphology despite optimised medical therapy)
- Inability to undergo CMR (i.e. severe claustrophobia or MRI contraindications)
- Life expectancy <12 months
- Indication for an implantable cardioverter defibrillator
- Presence of severe valve disease or mechanical valves
- Any prior attempt at implantation of an ICD, CRT, CSP
- Permanent AF with rapid ventricular response, unless pace and ablate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Rationale Right ventricular pacing (RVP) is an established and effective therapy for patients with atrioventricular (AV) block. However, frequent RVP has been associated with left ventricular (LV) dyssynchrony and may progess heart failure. Conduction system pacing (CSP), a recently introduced alternative to RVP, aims to preserve physiological ventricular activation by engaging the heart's native conduction system. CSP includes diverse pacing approaches such as selective or non-selective His-bundle pacing, selective left bundle pacing, and LV-septal pacing, each with varying levels of fidelity in reproducing normal conduction. The mechanical impact of these distinct CSP strategies on left and right ventricular (RV) performance remains poorly understood.
Cardiac magnetic resonance imaging (CMR), a non-invasive and highly accurate tool for assessing cardiac structure and function, is uniquely positioned to elucidate the effects of CSP and RVP on cardiac performance. This trial aims to evaluate the comparative mechanical effects of these pacing strategies, potentially identifying the optimal approach for improving outcomes in patients with AV block.
Read more
Objective To investigate and compare the effects of CSP and RVP on cardiac performance, as assessed by CMR and electrocardiographic imaging (ECG-imaging).
Main Trial Endpoints The primary endpoints are measures of LV and RV performance assessed via CMR, including: ventricular volumes, ejection fraction (EF), and myocardial strain
Secondary Trial Endpoints
Secondary endpoints include:
Safety and Feasibility:
- Adverse events (e.g., troponin release, lead displacement, arrhythmias, heart failure).
- Technical feasibility (e.g., ease of device implantation, ability to maintain proper pacing).
Electrophysiological Assessment:
- Degree of selectivity in engaging the native conduction system.
- Ventricular activation times as assessed by ECG-imaging.
Trial Design This is a randomized, controlled, single blind, two-center crossover trial. Participants will undergo CSP and RVP in a randomized sequence, each for six months. CMR and ECG-imaging will be performed at 6 months (end of the first pacing phase) and 12 months (end of the second pacing phase).
Trial Population The trial will enroll 88 patients with a normal of at most mildly reduced ejection fraction and an indication for ventricular pacing.
Interventions Participants will undergo CMR and ECG-imaging at 6 months and 12 months.
Ethical Considerations This trial is designed to advance understanding of the mechanical and clinical effects of CSP relative to RVP in patients with AV block. The anticipated benefits include improved cardiac performance and enhanced quality of life. The primary burden to participants is the requirement for an additional CMR scan, which may be perceived as inconvenient or even stressful. The trial minimizes risk by utilizing established clinical procedures and closely monitoring participants for adverse events.
- Conditions
- Heart Failure, AV Block
- Being tested
- Ventricular pacing
- Medical subject headings
- Heart Failure, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular pacingDevice
Participants will undergo conductionsystem pacing and right ventricular pacing in a randomized sequence, each for six months. After each phase, patients will undergo a CMR scan and advanced ECG imaging
| Study group | Role | What they receive |
|---|---|---|
| Conduction system pacing | Active comparator | Not described Receives: Device: Ventricular pacing |
| Right ventricular pacing | Active comparator | Not described Receives: Device: Ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is LV ejection fraction measured on CMR
Measured: At 6 months after crossover
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luuk Hopman, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843135
- Sponsor's protocol ID
- NL88751.018.25
- Acronym
- HARMONY
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchrony in Cardiac Conduction: Assessing the Effects of Pacing on Cardiac Performance Through Magnetic Resonance Imaging and Advanced ECG-imaging
- ClinicalTrials.gov ID
- NCT06843135
- Acronym / sponsor ID
- HARMONY / NL88751.018.25
- Conditions
- Heart Failure, AV Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 24 Feb 2025 (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.
Rationale Right ventricular pacing (RVP) is an established and effective therapy for patients with atrioventricular (AV) block. However, frequent RVP has been associated with left ventricular (LV) dyssynchrony and may progess heart failure. Conduction system pacing (CSP), a recently introduced alternative to RVP, aims to preserve physiological ventricular activation by engaging the heart's native conduction system. CSP includes diverse pacing approaches such as selective or non-selective His-bundle pacing, selective left bundle pacing, and LV-septal pacing, each with varying levels of fidelity in reproducing normal conduction. The mechanical impact of these distinct CSP strategies on left and right ventricular (RV) performance remains poorly understood.
Cardiac magnetic resonance imaging (CMR), a non-invasive and highly accurate tool for assessing cardiac structure and function, is uniquely positioned to elucidate the effects of CSP and RVP on cardiac performance. This trial aims to evaluate the comparative mechanical effects of these pacing strategies, potentially identifying the optimal approach for improving outcomes in patients with AV block.
Objective To investigate and compare the effects of CSP and RVP on cardiac performance, as assessed by CMR and electrocardiographic imaging (ECG-imaging).
Main Trial Endpoints The primary endpoints are measures of LV and RV performance assessed via CMR, including: ventricular volumes, ejection fraction (EF), and myocardial strain
Secondary Trial Endpoints
Secondary endpoints include:
Safety and Feasibility:
- Adverse events (e.g., troponin release, lead displacement, arrhythmias, heart failure).
- Technical feasibility (e.g., ease of device implantation, ability to maintain proper pacing).
Electrophysiological Assessment:
- Degree of selectivity in engaging the native conduction system.
- Ventricular activation times as assessed by ECG-imaging.
Trial Design This is a randomized, controlled, single blind, two-center crossover trial. Participants will undergo CSP and RVP in a randomized sequence, each for six months. CMR and ECG-imaging will be performed at 6 months (end of the first pacing phase) and 12 months (end of the second pacing phase).
Trial Population The trial will enroll 88 patients with a normal of at most mildly reduced ejection fraction and an indication for ventricular pacing.
Interventions Participants will undergo CMR and ECG-imaging at 6 months and 12 months.
Ethical Considerations This trial is designed to advance understanding of the mechanical and clinical effects of CSP relative to RVP in patients with AV block. The anticipated benefits include improved cardiac performance and enhanced quality of life. The primary burden to participants is the requirement for an additional CMR scan, which may be perceived as inconvenient or even stressful. The trial minimizes risk by utilizing established clinical procedures and closely monitoring participants for adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conduction system pacing | Active comparator | Device: Ventricular pacing |
| Right ventricular pacing | Active comparator | Device: Ventricular pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age ≥ 18 years
- Patients with a left ventricular ejection fraction of ≥35%
- Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >20% including:
- Third degree AV block
Key exclusion criteria (8 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- CRT indication (patients with heart failure (NYHA >1) in sinus rhythm with left ventricular ejection fraction (LVEF) <35%, QRS duration >150 ms, and left bundle branch block (LBBB) QRS morphology despite optimised medical therapy)
- Inability to undergo CMR (i.e. severe claustrophobia or MRI contraindications)
- Life expectancy <12 months
- Indication for an implantable cardioverter defibrillator
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 |
|---|---|---|
| Ventricular pacingParticipants will undergo conductionsystem pacing and right ventricular pacing in a randomized sequence, each for six months. After each phase, patients will undergo a CMR scan and advanced ECG imaging | Device | Conduction system pacing, Right ventricular pacing |
Primary outcome
The primary endpoint is LV ejection fraction measured on CMR
Time frame: At 6 months after crossover
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 24 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ventricular pacing in people with Heart Failure and AV Block, run by Amsterdam UMC, location VUmc.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Feb 2025. 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?
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 Dr. Hopman (+31204444105, l.hopman@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is LV ejection fraction measured on CMR (time frame: At 6 months after crossover). 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 24 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.