Trials / Completed
CompletedNCT02577887
Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,101 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.
Detailed description
The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers. The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Patients implanted with a St. Jude Medical pacemakers |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2017-11-25
- Completion
- 2017-12-15
- First posted
- 2015-10-16
- Last updated
- 2020-03-09
- Results posted
- 2019-11-18
Locations
4 sites across 4 countries: France, Germany, Italy, Japan
Source: ClinicalTrials.gov record NCT02577887. Inclusion in this directory is not an endorsement.