Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation/non-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle Branch Block after Transcatheter Aortic Valve Implantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presenting with New Onset Persistent Left Bundle Branch Block, defined as a new Left Bundle Branch Block >150 ms that persists at least two days after Transcatheter Aortic Valve Implantation and is stable

With an anticipated life expectancy >1 year

Who consent to participate to the study

Disqualifiers

Documented high grade Atrio Ventricular block (Atrio Ventricular block of a degree higher than Mobitz I)

Persistent PR interval prolongation > 240 ms

Occurrence of syncope or sudden cardiac death,

Identification of any indisputable criteria for Pacemaker implantation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcatheter Aortic Valve Implantation

    Procedure/Surgery

    Transcatheter Aortic Valve Implantation is the implantation of a biological aortic valve percutaneously

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Electrocardiogram Ambulatory Monitoring for 1 month and immediate dischargeActive comparator 1 intervention
Group B: Electrocardiogram Ambulatory Monitoring for infra-hisian conduction evaluationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Alive status with appropriate Pacemaker implantation/non-implantation

The primary endpoint of this study is the alive status with appropriate Pacemaker implantation/non-implantation, at 12 months after randomization. * Appropriate Pacemaker non-implantation: \- Absence of syncope or sudden cardiac death in a non-implanted patient * Appropriate Pacemaker implantation: * Documented indisputable criteria for Pacemaker implantation * Absence of syncope or sudden cardiac death * Absence of upgrading procedure

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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