ElectroPhySiological Characterization Of the Arrhythmia Substrate for Sudden Cardiac Death PrEdiction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Bordeaux

About this trial

EP-SCOPE is a prospective, multicentric, non-randomized pilot study that aims to estimate the risk of life-threatening ventricular arrhythmia through use of advanced electrophysiological studies in patients with ischemic or non-ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) \<50% and risk factors of ventricular arrhythmia, otherwise not considered for implantation of an implantable cardioverter defibrillator (ICD).

The objective is to assess the effectiveness of a risk stratification strategy based on detailed electrophysiological exploration of the left ventricle and programmed ventricular stimulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with cardiomyopathy with 35%<LVEF<50% and at least one risk factor

Patients with cardiomyopathy with LVEF≤35% and an indication for cardiac resynchronisation

Disqualifiers

Patients who are minors or aged 80 or over

Patients with unstable coronary artery disease

Myocardial infarction less than 40 days old

Coronary revascularisation <90 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implantation of an ICD

    Device

    Implantation of an ICD

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Implantation of an ICDExperimental treatment 1 intervention
Group B: Clinical follow-upNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Occurrence of major rhythmic events

Follow-up on Occurrence of major rhythmic events

Time frame
60 months

Secondary outcomes

1

Surfaces distributions of abnormal ventricular potentials

Time frame
Day 1
2

Spatial distributions of abnormal ventricular potentials

Time frame
Day 1
3

Purkinje potentials in induced arrhythmias

Presence or absence

Time frame
Day 1

Other outcomes

Sponsors and contacts

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