CardioMEMS HF System Coverage With Evidence Development Study

Abbott Medical Devices1,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Heart Failure

Interventions

CardioMEMS HF SystemDEVICE

PA Pressure Sensor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Abbott

Pleasanton, California, United States

RECRUITING

Outcomes

Primary Outcomes

HF Hospitalization Rate.

Compare HF hospitalization rate between the treatment and control groups.

Time frame: 2 years

Secondary Outcomes

Two-Year Survival

Compare survival between the treatment and control groups.

Time frame: 2 years

Central Contacts

Nessa Johnson

CONTACT

612-283-3865 nessa.johnson@abbott.com

Data from ClinicalTrials.gov

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