Trials / Completed
CompletedNCT02698670
Prospective Registry on User Experience With The Mapping System For Ablation Procedures
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 577 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.
Detailed description
The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure with use of a 3D Mapping system. The study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used for the planning of future clinical trials.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Rhythmia mapping system | A 3-D Cardiac Mapping system |
| DEVICE | IntellaMap Orion mapping catheter | A diagnostic basket mapping catheter |
Timeline
- Start date
- 2016-05-25
- Primary completion
- 2017-05-01
- Completion
- 2017-05-01
- First posted
- 2016-03-04
- Last updated
- 2018-01-25
Locations
28 sites across 8 countries: United States, Australia, France, Germany, Hong Kong, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02698670. Inclusion in this directory is not an endorsement.