Trials / Completed
CompletedNCT02167789
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 520 (actual)
- Sponsor
- LivaNova · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
Detailed description
The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Paradym CRT 8770 |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2014-06-19
- Last updated
- 2014-06-19
Locations
50 sites across 9 countries: United States, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02167789. Inclusion in this directory is not an endorsement.