NCT06061978

Brief Summary

The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Progress70%
Nov 2023May 2027

First Submitted

Initial submission to the registry

September 25, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

September 25, 2023

Last Update Submit

February 5, 2026

Conditions

Atrial Fibrillation Rapid

Outcome Measures

Primary Outcomes (1)

  • Maximum Oxygen Consumption (VO2 max) in mL/min/kg.

    18 months

Secondary Outcomes (5)

  • walking test distance covered

    18 months

  • echography criteria: LVEF (%), indexed left ventricular end-systolic volume (mL/m2), indexed cardiac output (L/min/m2), inter-ventricular asynchrony criteria (aortic pre-ejection time - pulmonary pre-ejection time)

    18 months

  • Determination of NT pro BNP or BNP

    18 months

  • Physical component of quality-of-life scale (SF-36)

    18 months

  • Medico-economic criteria: incremental cost-utility ratio of LBTP versus RVP

    18 months

Study Arms (2)

left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)

EXPERIMENTAL
Procedure: left bundle branch of His pacingProcedure: right ventricular pacing

right ventricular pacing (RVP) then left bundle branch of His pacing (LBTP)

EXPERIMENTAL

Interventions

right ventricular pacingPROCEDURE

right ventricular pacing

left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)
left bundle branch of His pacingPROCEDURE

left bundle branch of His pacing

left bundle branch of His pacing (LBTP) then right ventricular pacing (RVP)

Eligibility Criteria

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

You may qualify if:

  • \) Membership of a social security scheme 6) Patient follow-up feasible 7) Patient has read and understood the information leaflet and signed the informed consent form

You may not qualify if:

  • Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale \< 5).
  • Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship.
  • Patient participating in another interventional trial
  • Any history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.
  • Pregnant, parturient or breast-feeding women, or those without proven contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de CAEN

Caen, France

RECRUITING

Study Officials

  • Corentin CHAUMONT, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corentin CHAUMONT, MD

CONTACT

232888116corentin.chaumont@chu-rouen.fr

Armelle GUIDOTTI

CONTACT

232888265armelle.guidotti@chu-rouen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

September 29, 2023

Study Start

November 27, 2023

Primary Completion (Estimated)

May 27, 2027

Study Completion (Estimated)

May 27, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)