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)

Completed

• Conditions: Severe Cardiac Insufficiency

• Registration Number: NCT02873169
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-19
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 681

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of early VAs (<30 days post operatively) and late VAs (>30 days post operatively) in patient with CF-LVAD with or without ICD	30 days	Clinical, biological, hemodynamic and rhythmic data

Secondary Outcome Measures

Name	Time	Method
Mortality in patients with CF-LVAD with or without VAs	30 days
Mortality in patients with CF-LVAD with or without ICD	30 days

Trial Locations

Locations (20)

CHU de Grenoble; 🇫🇷 Grenoble, France

AP-HM - Hôpital de la Timone; 🇫🇷 Marseille, France

CHRU de Montpellier; 🇫🇷 Montpellier, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CHRU de Nancy; 🇫🇷 Nancy, France

CHU de Rouen; 🇫🇷 Rouen, France

APHP - Hôpital Bichat; 🇫🇷 Paris, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHRU de Tours; 🇫🇷 Tours, France

CHRU de Lille; 🇫🇷 Lille, France

Centre chirurgical Marie-Lannelongue; 🇫🇷 Le Plessis-Robinson, France

CHU Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Nantes; 🇫🇷 Nantes, France

Hospices Civils de Lyon - Hôpital Louis Pradel; 🇫🇷 Bron, France

CHU de Caen; 🇫🇷 Caen, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU de Dijon; 🇫🇷 Dijon, France