Not Yet RecruitingNot Applicable

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

320 participantsStarted 2023-12-01

Plain-language summary

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

Who can participate

Age range70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Other indications for pacemaker implantation or previously implanted pacemaker * Life expectancy \< 1 year * No written informed consent

What they're measuring

Events in the control arm

Timeframe: 12 months

Trial details

NCT IDNCT05889208

SponsorAalborg University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Ashkan Eftekhari, MD PhD

+4597664465 asef@rn.dk

View on ClinicalTrials.gov More Aortic Stenosis trials