About this trial
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:
* Prophylactic pacemaker implantation prior TAVI * Conservative strategy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing TAVI indicated by severe valvular aortic stenosis
Written informed consent
Left ventricular ejection fraction ≥ 40 %
Persistent RBBB in 12-lead electrocardiogram (RSR' pattern in V1-3, QRS duration > 120 milliseconds, and wide S wave in leads I, aVL, V5-6)
Disqualifiers
Other indications for pacemaker implantation or previously implanted pacemaker
Life expectancy < 1 year
No written informed consent
Trial design
Parallel
Treatments tested in this trial
Prophylactic pacemaker implantation
DevicePacemaker implantation prior the TAVI-procedure
Treatment groups
Trial outcomes
Primary outcomes
Events in the control arm
Composite of all-cause mortality, unplanned pacemaker implantation and new onset of heart failure
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: