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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN91372291 |
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Date of registration:
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29/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Post-market clinical follow-up study evaluating the efficacy and safety of the wearable cardioverter-defibrillator (WCD) medical device 'LifeVest' in real-life settings in France
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Scientific title:
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Post-market clinical follow-up study evaluating the efficacy and safety of LifeVest in real-life settings in France |
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Date of first enrolment:
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01/03/2016 |
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Target sample size:
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550 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN91372291 |
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Study type:
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Observational |
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Study design:
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Post-market observational study (Prevention)
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Sabrina
Koschel |
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Address:
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Arnulstraße 19a
80335
Munich
Germany |
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Telephone:
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+49 89 990 1649 964 |
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Email:
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pms_lifevest@cri-muc.eu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients receiving a LifeVest prescription in clinical routine. The following indications are authority approved:
1. Implantable cardiac defibrillator (ICD) removal due to cardiac device infections
2. A bridge to heart transplantation
3. In the early post-MI period with left ventricular (LV) dysfunction (LVEF <30%)
4. Recent coronary revascularization with LV dysfunction (LVEF < 30%)
Exclusion criteria: Patients who are physically or mentally unable to handle and use the WCD device appropriately, as judged by their responsible physician.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sudden cardiac death (SCD)
Circulatory System
Sudden cardiac death (SCD)
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Intervention(s)
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Patients qualify for participation by wearing a LifeVest device in clinical routine. Mean WCD wearing time is anticipated to be three months. However, some indications for wearing the WCD may be longer (up to 6 months) or shorter (only one month). For patients who are listed for heart transplantation, the wearing time is scheduled until heart transplantation is performed, or an ICD will be implanted. The WCD (LifeVest) device directly transmits to a central data server in the USA, Pittsburgh, which is compiled in a central database to which the treating physician has access via an internet platform enabling him to review any potential arrhythmic event detected by the device.
Patients who have already completed use of LifeVest before start of the study in the corresponding study site can also be asked to consent for use of their clinical data.
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Primary Outcome(s)
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Success of LifeVest in terminating life-threatening ventricular arrhythmias, measured as the success rate of appropriate shocks. Data of all arrhythmic events will be transferred automatically from the LifeVest device to a central database. An independent Clinical Event Committee will during the study period use these data to adjudicate all arrhythmic events for adequate termination.
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Secondary Outcome(s)
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1. Use of LifeVest in patients at high risk for SCD in clinical practice (i.e. indications, duration of prescription, circumstances associated with the prescription)
2. Risk associated with LifeVest use is determined by measuring the amount of inappropriate shocks (one administered while a patient is not experiencing either sustained VT or VF) is assessed at the end of the study period
3. Patient safety while using LifeVest including cardiac and non-cardiac death, hospitalization, heart surgery, arrhythmic events and other cardiac events is measured through the review of patient medical notes at the end of the study period
4. Patient compliance is determined using the history of recorded appropriate WCD use during the wearing of the WCD (LifeVest ®) by the patients physician is assessed at the end of the study period
5. Factors influencing the non-compliance of patients (age, gender, neurologic function, co-morbidities etc.) is determined by the investigator at time of inclusion
6. Circumstances associated with the withdrawal of LifeVest (i.e. ICD implantation, heart transplantation, LVEF improvement) is determined by the investigator at the time of withdrawal
7. Technical malfunctions and misuses related to the device is determinded by the investigator at the end of the wearing period
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Secondary ID(s)
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15.10.2015
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Source(s) of Monetary Support
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ZOLL
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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