An interventional study of Ventricular pacing in Heart Failure and AV Block, sponsored by Amsterdam UMC, location VUmc. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Treatment
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:
Electrophysiological Assessment:
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 88 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Amsterdam UMC, location VUmc is the lead sponsor of 305 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Ventricular pacing
Device: Ventricular pacing
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
The primary endpoint is LV ejection fraction measured on CMR
Time frame: At 6 months after crossover
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Mar 2028, 36 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 36 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amsterdam UMC, location VUmc →