Trials / Completed
CompletedNCT03425188
Post Approval Study of the remedē System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 53 (actual)
- Sponsor
- Respicardia, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
Detailed description
This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.
Conditions
Timeline
- Start date
- 2018-06-28
- Primary completion
- 2020-08-04
- Completion
- 2020-08-04
- First posted
- 2018-02-07
- Last updated
- 2021-04-22
- Results posted
- 2021-04-22
Locations
17 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT03425188. Inclusion in this directory is not an endorsement.