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Clinical Trials/NCT02873169
NCT02873169
Completed
N/A

Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)

Rennes University Hospital20 sites in 1 country681 target enrollmentSeptember 2015
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ConditionsSevere Cardiac Insufficiency

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe Cardiac Insufficiency
Sponsor
Rennes University Hospital
Enrollment
681
Locations
20
Primary Endpoint
Occurrence of early VAs (<30 days post operatively) and late VAs (>30 days post operatively) in patient with CF-LVAD with or without ICD
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 31, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patient above 18 years old
  • •Patients with CF-LVAD with or without ICD

Exclusion Criteria

  • •Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Outcomes

Primary Outcomes

Occurrence of early VAs (<30 days post operatively) and late VAs (>30 days post operatively) in patient with CF-LVAD with or without ICD

Time Frame: 30 days

Clinical, biological, hemodynamic and rhythmic data

Secondary Outcomes

  • Mortality in patients with CF-LVAD with or without VAs(30 days)
  • Mortality in patients with CF-LVAD with or without ICD(30 days)

Study Sites (20)

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