Sudden Cardiac DeathWEARIT-FRNCT03319160
LifeVest Safety and Efficacy in Real Life Settings in France
An observational study of Sudden Cardiac Death and Left Ventricular Dysfunction, run by Zoll Medical Corporation at 2 sites in France.
Trial summary
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Cardiac Death, Left Ventricular Dysfunction, Cardiac Event
- What is being tested?
- Wearable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 1,164 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Feb 2017to 30 Mar 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
Who may be able to join
- Patients receiving a LifeVest prescription in clinical routine for the following indications:
- implantable cardiac defibrillator (ICD) removal due to cardiac device infections,
- a bridge to heart transplantation,
- in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF <30%),
- a recent coronary revascularization with LV dysfunction (LVEF < 30%).
- Patients who have given their consent to participate.
Who cannot join
- There are no exclusion criteria for this study
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
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
Read the detailed description
LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF <30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF < 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.
- 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
| Study group | Role | What they receive |
|---|---|---|
| All LifeVest Users | Patients who were prescribed and used a LifeVest in France Receives: Device: Wearable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
Secondary outcomes (2)
Survival During WCD Use
The number of patients that were alive at the end of the use of the Wearable Cardioverter Defibrillator (WCD) compared to the total population of patients prescribed the LifeVest
Measured: from start to end of WCD use (3 months typical prescription)
Quality of Life Relative to Health State
Measured through the administration of a patient quality of life survey. This survey has been used previously in a published study of patient quality of life.
Agreement score according to 5-point Likert scale (lower is better):
- = Strongly Agree
- = Agree
- = Neither Agree nor Disagree
- = Disagree
- = Strongly Disagree
Measured: Time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start2 Feb 2017
- Primary completion30 Sep 2018
- 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,164 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Szymkiewicz, MD, Study director, Zoll Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319160
- Sponsor's protocol ID
- 90D0130
- Acronym
- WEARIT-FR
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2017
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Garcia R, Warming PE, Narayanan K, Defaye P, Guedon-Moreau L, Blangy H, Piot O, Leclercq C, Marijon E; WEARIT-France Investigators. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study. Europace. 2023 May 19;25(5):euad062. doi: 10.1093/europace/euad062.
PubMed 37021342Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquie JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268.
PubMed 33257972
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France
- ClinicalTrials.gov ID
- NCT03319160
- Acronym / sponsor ID
- WEARIT-FR / 90D0130
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
Detailed description
LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF <30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF < 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All LifeVest Users | – | Device: Wearable Cardioverter DefibrillatorPatients who were prescribed and used a LifeVest in France |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- Patients receiving a LifeVest prescription in clinical routine for the following indications:
- Patients who have given their consent to participate.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Cardioverter DefibrillatorAlso: LifeVestA non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention | Device | All LifeVest Users |
Primary outcome
Appropriate Shock Events Per Patient
Time frame: start to end of WCD use (3 months typical prescription)
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.
Risk of Not Receiving Appropriate Shocks When Necessary
Time frame: from start to end of WCD use (3 months typical prescription)
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.
Inappropriate Shock Events Per Patient
Time frame: from start to end of WCD use (3 months typical prescription)
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.
2 secondary outcomes
Survival During WCD Use
Time frame: from start to end of WCD use (3 months typical prescription)
Quality of Life Relative to Health State
Time frame: Time of enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37021342Garcia R, Warming PE, Narayanan K, Defaye P, Guedon-Moreau L, Blangy H, Piot O, Leclercq C, Marijon E; WEARIT-France Investigators. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study. Europace. 2023 May 19;25(5):euad062. doi: 10.1093/europace/euad062.
- Derived from this study: PubMed 33257972Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquie JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Szymkiewicz, MD study director
Zoll Medical Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Left Ventricular Dysfunction, run by Zoll Medical Corporation at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate Shock Events Per Patient (time frame: start to end of WCD use (3 months typical prescription)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319160, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.