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)

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.

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Key information

Conditions

Severe Cardiac Insufficiency Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux, Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable cardioverter-defibrillator

Other

Collection of clinical, biological, hemodynamic and rhythmic data

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

Time frame: 30 days
Mortality in patients with CF-LVAD with or without ICD

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: ASSIST-ICD

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 19, 2016
Registry last updated: Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed