Recruiting

CardioMEMS

Sponsor:

Abbott Medical Devices

Code:

NCT06779552

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioMEMS HF System

Study Details

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.

Conditions

Heart Failure

Study ID

NCT06779552

Start date

Feb 7, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

Heart failure patients implanted with the CardioMEMS PA pressure sensor.

Control Group

Heart failure patients being managed without PA pressure-monitoring.

Interventions

CardioMEMS HF System

PA Pressure Sensor

Primary outcome measure

  • HF Hospitalization Rate. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Nessa Johnson

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

Locations

Abbott

Recruiting

Pleasanton, California, United States, 94588

Contacts

Nessa Johnson

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

More Information

Sponsor

Abbott Medical Devices

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-04-03.