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)

October 19, 2017 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

681

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33600
        • CHU de Bordeaux
      • Bron, France, 69677
        • Hospices Civils de Lyon - Hopital Louis Pradel
      • Caen, France
        • CHU de Caen
      • Clermont Ferrand, France, 63003
        • CHU Clermont Ferrand
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Dijon, France, 21079
        • CHU de Dijon
      • Grenoble, France, 38700
        • CHU de Grenoble
      • Le Plessis-Robinson, France, 92350
        • Centre chirurgical Marie-Lannelongue
      • Lille, France, 59037
        • CHRU de Lille
      • Marseille, France, 13385
        • AP-HM - Hôpital de la Timone
      • Montpellier, France, 34295
        • CHRU de Montpellier
      • Nancy, France, 54500
        • CHRU de Nancy
      • Nantes, France, 44000
        • CHU de Nantes
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • APHP - Hôpital BICHAT
      • Rennes, France, 35033
        • CHU de Rennes
      • Rouen, France, 76000
        • CHU de Rouen
      • Strasbourg, France, 67091
        • Hopitaux Universitaires de Strasbourg
      • Toulouse, France
        • CHU de Toulouse
      • Tours, France, 37170
        • CHRU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with continuous flow left ventricular assist device

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality in patients with CF-LVAD with or without VAs
Time Frame: 30 days
30 days
Mortality in patients with CF-LVAD with or without ICD
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (ESTIMATE)

August 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC15_8806_ASSIST-ICD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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