Status:
TERMINATED
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
Lead Sponsor:
LivaNova
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550...
Detailed Description
The study will particularly focus on a new sensor-based diagnostic feature, called PhD-Clinical Status (PhD). A dedicated PhD screen shows the trends of patients' ventilation levels at rest (MVR) and ...
Eligibility Criteria
Inclusion
- Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines.
- Documented chronic HF (NYHA Class II to IV) at the time of enrollment
- Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
- Signed and dated informed consent
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT01170624
Start Date
September 1 2009
End Date
September 1 2011
Last Update
January 12 2015
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen
Antwerp, Belgium, 2020
2
Centre Hospitalier Général
Albi, France, 81013
3
Centre Hospitalier Universitaire D'Amiens
Amiens, France, 80090
4
Chu Annecy
Annecy, France, 74011