Trials / Active Not Recruiting
Active Not RecruitingNCT03505801
Confirm Rx Insertable Cardiac Monitor SMART Registry
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,826 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Confirm Rx ICM insertion procedure | Insertion of Confirm Rx ICM device |
Timeline
- Start date
- 2018-04-24
- Primary completion
- 2019-09-19
- Completion
- 2026-03-31
- First posted
- 2018-04-23
- Last updated
- 2025-12-18
Locations
113 sites across 24 countries: United States, Algeria, Argentina, Austria, Belgium, Canada, Germany, Hungary, India, Israel, Italy, Japan, Kuwait, Latvia, Netherlands, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT03505801. Inclusion in this directory is not an endorsement.