About this trial
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Successful implantation of TAVI according to VARC-3 criteria.
Indication of cardiac pacing due to AV block according to ESC Guidelines.
LVEF> 50%.
The patient must indicate their acceptance to participate in the study by signing an informed consent document.
Disqualifiers
Ventricular dysfunction: LVEF <50%.
Transapical TAVI.
Participating currently in a clinical investigation that includes an active treatment.
Patients with left bundle branch block but without indication of pacing (AV block).
Trial design
Parallel
Treatments tested in this trial
Conduction system pacing
Procedure/SurgeryLeft bundle branch pacing or His bundle branch pacing
Right ventricular pacing
Procedure/SurgeryConventional pacing
Treatment groups
Trial outcomes
Primary outcomes
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.
Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement \> 1 point in NYHA class or \> 25% increase in the distance covered in the 6-minute walking test.
Secondary outcomes
Change in left ventricular ejection fraction.
Left ventricular ejection fraction (LVEF %) measured with Simpson method with echocardiography (Delta left ventricular ejection fraction: 12 months LVEF - baseline LVEF).
Correction of echocardiographic asynchrony: septal flash expressed in mm.
Correction of septal flash determined with echocardiography (M mode).
Distance covered in the 6-minute walking test.
Distance in meters walked in 6 minutes.
Change in NYHA (New York Heart Association) functional class.
NYHA functional class I, II, III, IV.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.