Sudden cardiac death (SCD) Circulatory System Sudden cardiac death (SCD)
Conditions
Interventions
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 longe
Sponsors
ZOLL
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients who are physically or mentally unable to handle and use the WCD device appropriately, as judged by their responsible physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Outcome results
None listed