CardioMEMS HF System Coverage with Evidence Development Study

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06779552
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.

Study Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-16
• Status Verified: 2025-02
• Study Start: 2025-02-07
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2032-03
• Study Completion: 2032-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 hospitalization, elevated BNP/NT-proBNP

Exclusion Criteria

1. Subject has history of heart transplant or durable mechanical circulatory device
2. Subject hospitalized with cardiogenic shock or sepsis
3. Subject received prior PA pressure sensor implant (control arm only)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HF Hospitalization Rate.	2 years	Compare HF hospitalization rate between the treatment and control groups.

Secondary Outcome Measures

Name	Time	Method
Two-Year Survival	2 years	Compare survival between the treatment and control groups.

Trial Locations

Locations (1)

Abbott; 🇺🇸 Pleasanton, California, United States