An interventional study of Prophylactic pacemaker implantation in Aortic Stenosis and Right Bundle-Branch Block, sponsored by Aalborg University Hospital. Not yet recruiting. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn about the safety and outcome of prophylactic pacemaker implantation in patients with right bundle-branch block undergoing trans-catheter aortic valve (TAVI) implantation in patients with severe aortic stenosis and left ventricular ejection fraction.Participants will be randomized to:
BACKGROUND Transcatheter aortic valve implantation (TAVI) is standard of care treatment for patients with severe aortic stenosis ≥ 75 years and/or not eligible for surgical aortic valve replacement 1. There are two types of prosthetic valves: balloon expandable (BE) and self-expandable (SE) types with their distinct features 2. The TAVI-procedure and preexisting conditions in this population entails a risk of permanent pacemaker implantation following TAVI due to conduction disturbances related to the valve implantation and valve type (BE vs. SE). The rate of permanent pacemaker implantation after TAVI is between 2.3 - 36 % depending on valve type and pre-existing conditions3. Major risk factors are right bundle branch block (RBBB), left ventricular outflow track calcification, deeper valve implantation, and SE valves4. Pre-existing RBBB in patients undergoing TAVI occurs in 10% of the cases and it is associated with poor outcome5 in terms of higher pacemaker rate and mortality. Advanced conduction disturbances in patients with pre-existing RBBB occur within three days after the TAVI-procedure6. Hence, pre-existing RBBB is a major risk factor in the TAVI-population with higher mortality7 and needs special attention in peri-operative care. Current European Society Cardiology guidelines do not recommend prophylactic pacemaker implantation in patients without indication for permanent pacing8. However, cardiac pacing is associated with a risk of complications and development of heart failure9, and there is no randomized trial demonstrating a benefit of prophylactic pacemaker implantation in patients with pre-existing RBBB. Although previous observational data suggest prophylactic pacemaker implantation in patients with pre-existing RBBB shortens the TAVI procedure and prevents rehospitalization due to heart block10. Hence, there is a gap in knowledge regarding the outcome of prophylactic permanent pacemaker implantation in patients undergoing TAVI with pre-procedural RBBB and additional risk factors for need of post-procedural permanent pacing. This study aims to evaluate the clinical outcome and safety of prophylactic pacemaker implantation in this high-risk patient group versus a conservative strategy in a randomized clinical trial.
PURPOSE To evaluate safety and outcomes of prophylactic permanent pacemaker implantation in patients with RBBB undergoing TAVI.
HYPOTHESIS Prophylactic permanent pacemaker implantation reduces composite primary outcome in patients with RBBB undergoing TAVI.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 320 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
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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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Brady-pacemaker implantation prior the TAVI-procedure. Pacemaker modus is according to local conditions.
Device: Prophylactic pacemaker implantation
Pacemaker implantation after TAVI if atrioventricular block occurs.
Pacemaker implantation prior the TAVI-procedure
Events in the control arm
Composite of all-cause mortality, unplanned pacemaker implantation and new onset of heart failure
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Start is estimated for Dec 2023; primary completion for Dec 2026, 36 months later.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 36 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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