His Bundle Pacing Versus Right Ventricular Pacing | NCT04672408

Studies
His Bundle Pacing Versus Right Ventricular Pacing

NCT04672408

Sponsor

University Hospital, Geneva

Status

Terminated

Last Update Posted

Apr 9, 2025Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Pacing-Induced Cardiomyopathy

Interventions

His bundle pacing
Right ventricular pacing

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment since the advent of left bundle branch area pacing

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Apr 4, 2025Actual

Completion Date

Apr 4, 2025Actual

First Submitted Date

Nov 28, 2020

First Submission Date that Met QC Criteria

Dec 16, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2025

Last Update Posted Date

Apr 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Monocentric, randomized, double-blind comparative crossover clinical study.

Patients with a standard pacing indication with >20% ventricular pacing, with a baseline LVEF >40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
His bundle pacing	Device	Pacing with capture of the His bundle	His bundle pacing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction	Assessed by gated Equilibrium Radionuclide Angiography	6 months

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular peak filling rate (EDV/s)	Assessed by gated Equilibrium Radionuclide Angiography	6 months
NYHA functional class	Investigator evaluation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unable to sign an informed consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haran Burri, MD	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Geneva		Geneva	Canton of Geneva	1211	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Yareta data repository

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

At the ocmpletion of the study

Access Criteria

Open access for at least 15 years (as per Swiss law)

URL

Not provided