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Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation

NCT ID: NCT06061978

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2027-05-27

Brief Summary

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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

Detailed Description

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Conditions

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Atrial Fibrillation Rapid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

left bundle branch of His pacing

Intervention Type PROCEDURE

left bundle branch of His pacing

right ventricular pacing

Intervention Type PROCEDURE

right ventricular pacing

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

Group Type EXPERIMENTAL

left bundle branch of His pacing

Intervention Type PROCEDURE

left bundle branch of His pacing

right ventricular pacing

Intervention Type PROCEDURE

right ventricular pacing

Interventions

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left bundle branch of His pacing

left bundle branch of His pacing

Intervention Type PROCEDURE

right ventricular pacing

right ventricular pacing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1/ Pacemaker implanted patient with LBTP lead and back-up right ventricular lead who subsequently underwent successful atrioventricular node ablation for rapid AF 2) NAV ablation procedure performed less than 15 days ago 3) Age ≥ 18 years 4) Woman of childbearing age with effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and for the duration of the study, and a negative urine pregnancy test by B-HCG at inclusion Or, Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).

5\) 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

Exclusion Criteria

1. Impairment of autonomy such that a maximal cardiorespiratory effort test (VO2 Max test) cannot be performed under good conditions (ADL scale \< 5).
2. LVEF \< 40% at inclusion
3. Person deprived of liberty by an administrative or judicial decision, or person under court protection, sub-guardianship or curatorship.
4. Patient participating in another interventional trial
5. 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.
6. Pregnant, parturient or breast-feeding women, or those without proven contraception
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corentin CHAUMONT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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CHU de CAEN

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corentin CHAUMONT, MD

Role: CONTACT

Phone: 232888116

Email: [email protected]

Armelle GUIDOTTI

Role: CONTACT

Phone: 232888265

Email: [email protected]

Facility Contacts

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Pierre OLLITRAULT, Pr

Role: primary

Other Identifiers

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2021/0379/HP

Identifier Type: -

Identifier Source: org_study_id