Prophylactic Permanent Pacemaker in Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Implantation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorAalborg University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Prophylactic pacemaker implantation

    Device

    Pacemaker implantation prior the TAVI-procedure

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Prophylactic pacemaker implantationActive comparator 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Events in the control arm

Composite of all-cause mortality, unplanned pacemaker implantation and new onset of heart failure

Time frame
12 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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