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)

Severe Cardiac Insufficiency Clinical Trial

— ASSIST-ICD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873169
• Other study ID #: 35RC15_8806_ASSIST-ICD
• Status: Completed
• Phase: N/A
• First received: August 16, 2016
• Last updated: October 19, 2017
• Start date: September 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 681
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Severe Cardiac Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hospices Civils de Lyon - Hôpital Louis Pradel	Bron
France	CHU de Caen	Caen
France	CHU Clermont Ferrand	Clermont Ferrand
France	Hôpital Henri Mondor	Créteil
France	CHU de Dijon	Dijon
France	CHU de Grenoble	Grenoble
France	Centre chirurgical Marie-Lannelongue	Le Plessis-Robinson
France	CHRU de Lille	Lille
France	AP-HM - Hôpital de la Timone	Marseille
France	CHRU de Montpellier	Montpellier
France	CHRU de Nancy	Nancy
France	CHU de Nantes	Nantes
France	APHP - Hôpital Bichat	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	CHU de Rennes	Rennes
France	CHU de Rouen	Rouen
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of early VAs (<30 days post operatively) and late VAs (>30 days post operatively) in patient with CF-LVAD with or without ICD	Clinical, biological, hemodynamic and rhythmic data	30 days
Secondary	Mortality in patients with CF-LVAD with or without VAs		30 days
Secondary	Mortality in patients with CF-LVAD with or without ICD		30 days