NCT04672408

Brief Summary

This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)\>40%. The primary outcome measure is LVEF.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

November 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3.7 years

First QC Date

November 28, 2020

Last Update Submit

April 6, 2025

Conditions

Pacing-Induced Cardiomyopathy

Keywords

His bundle pacingRight ventricular pacingLeft ventricular systolic function

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    Assessed by gated Equilibrium Radionuclide Angiography

    6 months

Secondary Outcomes (7)

  • Left ventricular peak filling rate (EDV/s)

    6 months

  • NYHA functional class

    6 months

  • 6-minute walk test

    6 months

  • Quality of life measure by SF-36 questionnaire

    6 months

  • Right ventricular ejection fraction

    6 months

  • +2 more secondary outcomes

Study Arms (2)

His bundle pacing

ACTIVE COMPARATOR

Pacing programmed from the His bundle lead

Device: His bundle pacing

Right ventricular pacing

PLACEBO COMPARATOR

Pacing programmed from the right ventricular lead

Device: Right ventricular pacing

Interventions

His bundle pacingDEVICE

Pacing with capture of the His bundle

His bundle pacing
Right ventricular pacingDEVICE

Pacing from the right ventricular lead (septal or apical)

Right ventricular pacing

Eligibility Criteria

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

You may qualify if:

  • Baseline LVEF\>40%
  • Standard pacing indication with \>20% VP
  • Functional His bundle lead with confirmed His capture
  • Functional right ventricular lead with myocardial capture

You may not qualify if:

  • Unable to sign an informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Study Officials

  • Haran Burri, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized crossover double-blind
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 17, 2020

Study Start

August 1, 2021

Primary Completion

April 4, 2025

Study Completion

April 4, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Yareta data repository

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
At the ocmpletion of the study
Access Criteria
Open access for at least 15 years (as per Swiss law)

Locations

CH(1)