Trials / Terminated
TerminatedNCT01170624
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 388 (actual)
- Sponsor
- LivaNova · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.
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 under effort (MVE), and the corresponding level of activity, day-by-day, over a period of 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ICD | Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250 |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2010-07-27
- Last updated
- 2015-01-12
Locations
25 sites across 5 countries: Belgium, France, Germany, Italy, Portugal
Source: ClinicalTrials.gov record NCT01170624. Inclusion in this directory is not an endorsement.