Clinical Status Monitoring in ICD Patients by PhD Functio
Not Applicable
- Conditions
- Patients with implanted ICD or CRT-D device
- Registration Number
- JPRN-UMIN000005190
- Lead Sponsor
- Sorin CRM SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 558
Inclusion Criteria
Not provided
Exclusion Criteria
-Any contraindication for ICD therapy -Abdominal implantation site -Acute myocarditis -Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month -Planned heart transplant -Mechanical tricuspid valve -Unable to perform the 6 minute Walking Test at time of enrollment -Already included in another clinical study -Life expectancy less than 13 months -Inability to understand the purpose of the study or refusal to cooperate -Inability or refusal to provide informed consent -Under guardianship -Age of less than 18 years -Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that PhD curves allow the evaluation of the patients' clinical status evolution with an agreement correlation of +67%, compared to a standard clinical method.
- Secondary Outcome Measures
Name Time Method -The sensitivity and specificity of PhD functions to detect clinically relevant events,whether HF-related or not. -The time between the PhD indication and the clinically relevant event occurrence. -To classify (origin and number) the clinically relevant events, per patient group, and to determine a correlation with the percentage of ventricular pacing. -To collect at least fifty (50) complete recordings for each group of patient (CRT-D, DR/VR) -To evaluate and report the following incidence of adverse events (AEs) in the studied population, devices-related AEs with actual or potential effect on the patient, serious AEs not related to the device, mortality, and unanticipated AEs.