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Determination of Risk Factors of Ventricular Arrhythmias (VAs) After Implantation of Continuous Flow Left Ventricular Assist Device With Continuous Flow Left Ventricular Assist Device (CF-LVAD) (ASSIST-ICD)

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ClinicalTrials.gov Identifier: NCT02873169
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Severe Cardiac Insufficiency Other: Implantable cardioverter-defibrillator

Study Design
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Study Type : Observational
Actual Enrollment : 681 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)
Study Start Date : September 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

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Groups and Cohorts
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Intervention Details:
  • Other: Implantable cardioverter-defibrillator
    Collection of clinical, biological, hemodynamic and rhythmic data

Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mortality in patients with CF-LVAD with or without VAs [ Time Frame: 30 days ]
  2. Mortality in patients with CF-LVAD with or without ICD [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with continuous flow left ventricular assist device
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873169


Locations
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Sponsors and Collaborators
Rennes University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02873169    
Other Study ID Numbers: 35RC15_8806_ASSIST-ICD
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rennes University Hospital:
Left ventricular assist device
Ventricular Arrhythmias
Implantable Cardioverter-defibrillator
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases