Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Conduction system pacing

    Procedure/Surgery

    Left bundle branch pacing or His bundle branch pacing

  • Right ventricular pacing

    Procedure/Surgery

    Conventional pacing

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Conduction system pacingExperimental treatment 1 intervention
Group B: Right ventricular pacingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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).

Time frame
12 months.
2

Correction of echocardiographic asynchrony: septal flash expressed in mm.

Correction of septal flash determined with echocardiography (M mode).

Time frame
30 days; 12 months.
3

Distance covered in the 6-minute walking test.

Distance in meters walked in 6 minutes.

Time frame
30 days; 12 months.
4

Change in NYHA (New York Heart Association) functional class.

NYHA functional class I, II, III, IV.

Time frame
30 days; 12 months.

Other outcomes

Sponsors and contacts

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