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OPTImizing Lead Placement in Patients Requiring Pacemaker After Cardiac Surgery

ConditionsAtrioventricular BlockCardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

Conventional right ventricular pacing has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes. To lessen the burden of pacing-induced cardiomyopathy, the adoption of conduction system pacing has increased in recent years. In patients with normal cardiac function, measured as left ventricular ejection fraction, the superiority of conduction system pacing is less clear. As a result, both pacing strategies remain in widespread clinical use.

Patients undergoing cardiac surgery represent a vulnerable cohort for pacing-induced cardiomyopathy, given their established structural heart disease, and postoperative atrioventricular block remains a common occurrence in these patients.

This multicenter randomized trial aims to evaluate the use of conduction system pacing, in the form of left bundle branch area pacing, versus conventional pacing in patients with normal left ventricular ejection fraction after cardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

High degree atrioventricular block

Cardiac surgery within 30 days of pacemaker implantation

Written informed consent

Current left ventricular ejection fraction at or above 50%

Disqualifiers

Any concomitant condition that results in a life expectancy of less than 1 year

Planned for heart transplant or left ventricular assist device

Current dialysis

Not suitable according to the opinion of the investigators due to characteristics that interfere with the adherence to the study protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Left bundle branch area pacing

    Device

    Conventional pacing strategy versus conduction system pacing strategy in the form of left bundle branch area pacing

  • Conventional pacing strategy

    Device

    Conventional pacing strategy

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Conventional pacing strategyActive comparator 1 intervention
Group B: Left bundle branch area pacing strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in left ventricular ejection fraction

Change in left ventricular ejection fraction between enrollment and end of follow-up

Time frame
1 year

Secondary outcomes

1

Change in left ventricular end-diastolic diameter

Change in LVEDD from enrollment to end of study follow-up

Time frame
1 year
2

Clinical endpoints - composite

Composite of all-cause mortality, heart failure hospitalization, device-related hospitalization

Time frame
1 year
3

All-cause mortality

All-cause mortality

Time frame
1 year
4

Heart failure hospitalization

Heart failure hospitalization

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahlgrenska University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: