Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University Heart and Vascular Center

About this trial

In this prospective, randomized, multicenter, open-label interventional clinical trial, the investigators' aim to test the effect of Cardiac Resynchronization Therapy (CRT) in cases of new-onset and persistent Left Bundle Branch Block (LBBB) occurring in the context of Transcatheter Aortic Valve Implantation (TAVI), in patients with moderately reduced left ventricular systolic function (35% \< EF \< 55%). The investigators hypothesize that in patients with persistent LBBB developing after TAVI and mildly reduced left ventricular systolic function (35% \< EF \< 55%), early postoperative CRT implantation favorably influences the process of myocardial reverse remodeling by reducing electromechanical dyssynchrony, thereby decreasing the combined endpoint of heart failure-related hospitalizations and mortality at one year.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years

Successful and complication-free TAVI implantation for significant aortic stenosis

Signed informed consent after detailed patient information

New-onset LBBB wider than 130 ms after TAVI, persisting at the time of planned discharge (assessed postoperatively on or after day 5)(21)

Disqualifiers

Pre-existing right bundle branch block, or prior pacemaker/ICD implantation associated with significant (>20%) ventricular pacing

Progression of LBBB during hospitalization to a degree indicating pacemaker implantation (e.g., Mobitz II or third-degree AV block, alternating bundle branch block) before the planned discharge date

Concomitant severe valvular disease of other valves (mitral, pulmonary, or tricuspid)

Severe infection and/or septic state

Trial design

Design model

Parallel

Treatments tested in this trial

  • CRT implantation

    Device

    CRT implantation in patients with LVEF between 35-55% and new-onset LBBB wider than 130 ms after TAVI implantation

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: CRTActive comparator 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary outcome

Elapsed time to heart failure hospitalisation or all-cause mortality

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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