The CardioMEMS™ HF System has proven clinical benefit in a variety of clinical studies including 4 prospective trials totaling over 3,000 patients.
There are a variety of study designs that each come with inherent strengths and limitations. The CardioMEMS HF System has demonstrated significant clinical benefit regardless of study design.
The patient’s pre-implant history serves as the comparator to what the patient experiences prospectively after implant.
Retrospective analysis comparing similar baseline patients over the same time period. Those who were not implanted serve as the “control.”
The “gold standard” of clinical trials. All patients are implanted and followed prospectively. Patients are blinded to group assignment. Treatment is compared to control.
Study | Design | N | Reduce HFH | Reduce PAP | HFpEF Benefit | Safety | Increase QoL | Adherence | Elevated BNP |
---|---|---|---|---|---|---|---|---|---|
CHAMPION Pivotal Study 2016. Pivotal, Prospective Study - Abraham | RCT | N=550 | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Proven Management in HFpEF Patients - Adamson | RCT Subgroup | N=119 | ✓ | ✓ | |||||
Optimizing GDMT 2017. Retrospective, CHAMPION Subgroup - Givertz | Retrospective | N=456 | ✓ | ||||||
Real-world Study 2017. Retrospective - Heywood | Retrospective | N=2000 | ✓ | ✓ | ✓ | ||||
Economic Impact 2017. Retrospective - Desai | Retrospective Database | N=1114 | ✓ | ||||||
Propensity-Matched Cohort 2019. Retrospective - J. Abraham | Retrospective Database | N=2174 | ✓ | ||||||
MEMS-HF 2019. Prospective, multi-center, EU - Angermann | Single-arm | N=234 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
US Post-Approval Study 2020. Prospective - Shavelle | Single-arm | N=1200 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
GUIDE-HF Study 9 - Lindenfeld | RCT | N=1000 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
* Unpublished
Abraham et al.
Pivotal randomized prospective trial including 550 patients. Results showed a 33% annualized reduction in HFH regardless of ejection fraction.9
Adamson et al.
A CHAMPION trial subgroup analysis of 119 patients with preserved ejection fraction (>= 40%). At 6 months, heart failure hospitalizations were 46% lower in the treatment cohort when compared with the control. This is the first study to demonstrate the CardioMEMS™ HF System as the ONLY proven solution for HFpEF patients.8
MAT-2006905 v4.0
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