NCT06779552

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
71mo left

Started Feb 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Feb 2025Mar 2032

First Submitted

Initial submission to the registry

January 13, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

February 7, 2025

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

7.1 years

First QC Date

January 13, 2025

Last Update Submit

February 14, 2025

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • HF Hospitalization Rate.

    Compare HF hospitalization rate between the treatment and control groups.

    2 years

Secondary Outcomes (1)

  • Two-Year Survival

    2 years

Study Arms (2)

Treatment Group

Heart failure patients implanted with the CardioMEMS PA pressure sensor.

Device: CardioMEMS HF System

Control Group

Heart failure patients being managed without PA pressure-monitoring.

Interventions

CardioMEMS HF SystemDEVICE

PA Pressure Sensor

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include Heart Failure patients in the United States implanted with the CardioMEMS PA pressure sensor and HF patients being managed without PA pressure-monitoring.

You may qualify if:

  • Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
  • Subject \>=18 years of age at time of implant
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott

Pleasanton, California, 94588, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Nessa Johnson

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 16, 2025

Study Start

February 7, 2025

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

March 1, 2032

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

US(1)