CardioMEMS HF System Coverage With Evidence Development Study
Recruiting
Observational Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
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About This Trial
The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
2. Subject \>=18 years of age at time of implant
3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitaliz…
Contacts