NCT07795541

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
50mo left

Started Sep 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Dec 2030

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

4.2 years

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

Atrioventricular BlockCardiac Surgery

Keywords

Conduction system pacingAtrioventricular blockAfter cardiac surgeryLeft bundle branch area pacing

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricular ejection fraction

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

    1 year

Secondary Outcomes (6)

  • Change in left ventricular end-diastolic diameter

    1 year

  • Clinical endpoints - composite

    1 year

  • All-cause mortality

    1 year

  • Heart failure hospitalization

    1 year

  • Device-related hospitalization

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Conventional pacing strategy

ACTIVE COMPARATOR

This arm will receive a conventional pacemaker lead if they have atrioventricular block after cardiac surgery

Device: Conventional pacing strategy

Left bundle branch area pacing strategy

EXPERIMENTAL

This arm will receive a left bundle branch area pacing pacemaker lead if they have atrioventricular block after cardiac surgery

Device: Left bundle branch area pacing

Interventions

Left bundle branch area pacingDEVICE

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

Left bundle branch area pacing strategy
Conventional pacing strategyDEVICE

Conventional pacing strategy

Conventional pacing strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High degree atrioventricular block
  • Cardiac surgery within 30 days of pacemaker implantation
  • Written informed consent
  • Current left ventricular ejection fraction at or above 50%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andreas S Martinsson, MD, PhD

    Sahlgrensa university hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas S Martinsson, MD, PhD

CONTACT

+46313427717andreas.s.martinsson@vgregion.se

Alice David, MD

CONTACT

+313429684laura.david@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

August 31, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share