Trials / Completed
CompletedNCT01441583
Ingenio Device Algorithm Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 139 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
Detailed description
IVORY is a prospective, multi-center, randomized within-patient, single-blinded study to gather data to support Right Atrial Auto Threshold and RYTHMIQ
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RAAT | For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT) |
| DEVICE | RYTHMIQ | For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2012-06-01
- Completion
- 2013-04-01
- First posted
- 2011-09-27
- Last updated
- 2024-03-21
- Results posted
- 2024-03-21
Locations
21 sites across 12 countries: Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Malaysia, Netherlands, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01441583. Inclusion in this directory is not an endorsement.