Infarction, MyocardialWICD-MINCT05123885
Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction
An observational study of Infarction, Myocardial, run by Mathieu ECHIVARD at 40 sites in France.
Trial summary
Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infarction, Myocardial
- What is being tested?
- Study on Data
- How many people
- 1,032 participants
- Where
- 40 sitesFrance
- Study dates
- 2 Feb 2022to 8 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD
Who may be able to join
- Adult patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD before March 1, 2021.
Who cannot join
- Patient opposition to the use of their data.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
Chu Amiens
Amiens, 80054
Ch D'Auxerre
Auxerre, 89011
Chu Besancon
Besançon, 25030
Polyclinique Reims-Bezannes
Bezannes, 51430
Chu Bordeaux Pessac
Bordeaux
Ch Boulogne-Sur-Mer
Boulogne-sur-Mer, 62200
Chu Brest
Brest, 29200
Hospices Civils de Lyon
Bron, 69500
CHU de Caen
Caen
Chu Clermont-Ferrand
Clermont-Ferrand
Aphp Creteil
Créteil, 94000
Chu Dijon
Dijon, 21000
Clinique Essey Les Nancy
Essey-lès-Nancy, 54270
Chu Grenoble
La Tronche, 38700
Chu Lille
Lille
Chu Limoges
Limoges, 87042
Hospices Civils de Lyon
Lyon, 69004
Chu Aphm Marseille La Timone
Marseille
Hopital Prive Jacques Cartier
Massy, 91300
Chr de Metz Thionville
Metz, 57530
Chu Montpellier
Montpellier
Clinique Ambroise Pare
Nancy, 54100
Chu Nantes
Nantes
Chu Nimes
Nîmes, 30900
Chr D'Orleans
Orléans, 54100
Aphp Bichat
Paris, 75018
Php Hopital Europeen Georges Pompidou
Paris
Chu Reims
Reims, 51092
Chu Rennes
Rennes
Ch de Roubaix
Roubaix, 59100
Chu Rouen
Rouen, 76038
Chu Aphp Salpetriere
Saint-Denis
Clinique Cardiologique Du Nord Saint-Denis
Saint-Denis
Chu Saint-Etienne
Saint-Etienne
Chu Strasbourg
Strasbourg, 67000
Chu Toulouse
Toulouse
Clinique Pasteur Toulouse
Toulouse
Chu Tours Saint-Avertin
Tours
Hopital Nord Franche-Comte
Trévenans, 90400
CHRU de Nancy
Vandœuvre-lès-Nancy
About this study
Official title: Impact Pronostique d'un événement Rythmique Ventriculaire Durant le Port de la LifeVest en Post-infarctus
Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia [VT] or ventricular fibrillation [VF]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.
- Conditions
- Infarction, Myocardial
- Being tested
- Study on Data
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study on DataOther
Study on Data
| Study group | Role | What they receive |
|---|---|---|
| Experimental: | Adult patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD before March 1, 2021. Receives: Other: Study on Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
Measured: 12 months after ICD implantation
Secondary outcomes (7)
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
Measured: Up to 7 years after ICD implantation
Rate of rhythmic storm defined by ACC / AHA / ESC 2006 guidelines (≥3 episodes of VF, sustained VT or appropriate shock in 24 hours).
Measured: 12 months and up to 7 years after ICD implantation]
Rate of need to set-up left ventricular assist device (LVAD) or heart transplantation.
Measured: : 12 months and up to 7 years after ICD implantation
Rate of all-cause death.
Measured: 12 months and up to 7 years after ICD implantation
Rate of hospitalization for heart failure worsening.
Measured: 12 months and up to 7 years after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD, and mortality from any cause.
Measured: Frame: 12 months and up to 7 years after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD, and mortality from any cause.
Measured: 12 months and up to 7 years after ICD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start2 Feb 2022
- Primary completion28 Aug 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infarction, MyocardialStudies 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
- Retrospective
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathieu ECHIVARD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mathieu ECHIVARD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123885
- Sponsor's protocol ID
- 2021PI163
- Acronym
- WICD-MI
- Status last verified
- Mar 2023
- First submitted
- 9 Nov 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Pronostique d'un événement Rythmique Ventriculaire Durant le Port de la LifeVest en Post-infarctus
- ClinicalTrials.gov ID
- NCT05123885
- Acronym / sponsor ID
- WICD-MI / 2021PI163
- Conditions
- Infarction, Myocardial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- Mathieu ECHIVARDUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia [VT] or ventricular fibrillation [VF]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: | – | Other: Study on DataAdult patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD before March 1, 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD
Key inclusion criteria (1 listed)
- Adult patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD before March 1, 2021.
Key exclusion criteria (1 listed)
- Patient opposition to the use of their data.
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 |
|---|---|---|
| Study on DataStudy on Data | Other | Experimental: |
Primary outcome
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
Time frame: 12 months after ICD implantation
7 secondary outcomes
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
Time frame: Up to 7 years after ICD implantation
Rate of rhythmic storm defined by ACC / AHA / ESC 2006 guidelines (≥3 episodes of VF, sustained VT or appropriate shock in 24 hours).
Time frame: 12 months and up to 7 years after ICD implantation]
Rate of need to set-up left ventricular assist device (LVAD) or heart transplantation.
Time frame: : 12 months and up to 7 years after ICD implantation
Rate of all-cause death.
Time frame: 12 months and up to 7 years after ICD implantation
Rate of hospitalization for heart failure worsening.
Time frame: 12 months and up to 7 years after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD, and mortality from any cause.
Time frame: Frame: 12 months and up to 7 years after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD, and mortality from any cause.
Time frame: 12 months and up to 7 years after ICD implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infarction, Myocardial, run by Mathieu ECHIVARD at 40 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 1 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 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD. (time frame: 12 months after ICD implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2023.