Trials / Completed
CompletedNCT02279888
CardioMEMS HF System Post Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,214 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.
Detailed description
The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting. Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CardioMEMS HF System | Pulmonary artery pressure sensor |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2019-10-11
- Completion
- 2019-10-11
- First posted
- 2014-10-31
- Last updated
- 2024-04-17
- Results posted
- 2024-04-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02279888. Inclusion in this directory is not an endorsement.