LifeVest Safety and Efficacy in Real Life Settings in France

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Residents of France All patient who were prescribed a LifeVest were approached for consent. In addition to those prospectively enrolled, patients who had completed LifeVest use prior to the study start were eligible for retrospective enrollment.

Trial locations and contacts

2 sites in 1 country.

About this study

Official title: Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France

Conditions

Sudden Cardiac Death, Left Ventricular Dysfunction, Cardiac Event, Cardiac Arrythmias

Being tested

Wearable Cardioverter Defibrillator

Medical subject headings

Death, Sudden, Cardiac, Ventricular Dysfunction, Left, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Wearable Cardioverter DefibrillatorDevice

  Also called LifeVest

  A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Appropriate Shock Events Per Patient

   Appropriate shock events were defined as at least one WCD therapy shock delivered during sustained (at least 30 seconds) ventricular tachycardia (VT) or ventricular fibrillation (VF). All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings.

   For assessing incidence per 100 patient years, all appropriate shock events were considered.

   Measured: start to end of WCD use (3 months typical prescription)

2. Risk of Not Receiving Appropriate Shocks When Necessary

   While wearing a WCD, how often does a shock not occur when 1) VF or a sustained (> 30 seconds duration) VT occurs and 2) the response buttons are not used. Response button use is a surrogate for either a conscious patient or bystander presence.

   Measured: from start to end of WCD use (3 months typical prescription)

3. Inappropriate Shock Events Per Patient

   Inappropriate shock events were defined as having at least one WCD therapy shock delivered when neither sustained (at least 30 seconds in duration) ventricular tachycardia (VT) or ventricular fibrillation (VF) was not present. All shocks delivered within 24 hours of the first shock were considered one event. Adjudication of cardiac rhythms recorded during WCD therapy shocks was performed by 3 cardiologists familiar with device-recorded ECG tracings. For assessing incidence per 100 patient years, all inappropriate shock events were considered.

   Measured: from start to end of WCD use (3 months typical prescription)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Oct 2017
2. Study start2 Feb 2017
3. Primary completion30 Sep 2018
4. Study completion30 Mar 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.