Trials / Terminated
TerminatedNCT02470312
MediGuide Registry
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 578 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.
Detailed description
The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on: * The amount of fluoroscopy time and the radiation exposure * Total procedure time * Peri-procedural clinical event rate Additionally, this study will address the following * Identification of procedural challenges which may aid in developing future MediGuide tools * Evaluation of newly available MediGuide tools during the study * Correlation between MediGuide operator experience and the radiation exposure amount and time
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CRT implantation | It is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment |
| DEVICE | MediGuide | |
| PROCEDURE | EP |
Timeline
- Start date
- 2015-08-18
- Primary completion
- 2017-02-10
- Completion
- 2018-02-28
- First posted
- 2015-06-12
- Last updated
- 2019-02-04
- Results posted
- 2019-01-11
Locations
16 sites across 8 countries: United States, Australia, Austria, Canada, Estonia, Germany, Netherlands, Spain
Source: ClinicalTrials.gov record NCT02470312. Inclusion in this directory is not an endorsement.