NCT04529577

Brief Summary

The study compares standard right ventricle apical pacing with so called His-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. The primary outcome is left ventricular ejection fraction measured after 6 months.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

August 24, 2020

Last Update Submit

February 27, 2025

Conditions

His Bundle PacingHeart Failure, Systolic

Keywords

His bundle pacingConduction system pacingHeart failure, systolicQuality of lifeLeft ventricular ejection fraction

Outcome Measures

Primary Outcomes (1)

  • Ejection Fraction

    Absolute difference in left ventricular systolic ejection fraction (absolute percent)

    6 months

Secondary Outcomes (8)

  • Adverse events

    12 months

  • Left ventricular activation time

    6 months

  • NT-ProBNP

    6 months

  • QRS duration

    6 months

  • Left Ventricular Activation Time (LVAT)

    6 months

  • +3 more secondary outcomes

Study Arms (2)

His-bundle pacing first

EXPERIMENTAL

Patients are allocated to receive His-bundle pacing for a period of 6 months. Then the patients will cross over to traditional right ventricular (RV) apical pacing for 6 months.

Device: His-bundle pacing

RV apical pacing first

EXPERIMENTAL

Patients are allocated to receive traditional RV apical pacing for a period of 6 months. Then the patients will cross over to His-bundle pacing for 6 months.

Device: His-bundle pacing

Interventions

His-bundle pacingDEVICE

A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated). A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup.

His-bundle pacing firstRV apical pacing first

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AV block II or III with high expected pacing need
  • Left ventricular ejection fraction between 40% and 55% (inclusive)
  • Willing to participate and sign informed consent

You may not qualify if:

  • Under 18 years old
  • Pregnant
  • Hypertrophic cardiomyopathy
  • Cardiac sarcoidosis
  • Cardiac amyloidosis
  • Previous myocardial infarction within last 3 months
  • Ventricular septum defect or other other left ventricular corrective surgery
  • Congenital heart disease surgically corrected
  • Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Skane University Hospital

Lund, Sweden

RECRUITING

Norrland University Hospital

Umeå, Sweden

RECRUITING

Region Hallands Sjukhus Varberg

Varberg, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Rasmus Borgquist, MD PhD

    Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maiwand Farouq, MD, PhD

CONTACT

+ 46 40 336415‬maiwand.farouq@skane.se

Rasmus Borgquist, MD

CONTACT

+46 46 171010rasmus.borgquist@med.lu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patients and outcomes assessors are blinded. Staff involved in device programming are not blinded.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized double blinded crossover design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 28, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(3)