NCT02729922

Brief Summary

CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to help management of selected heart failure patients. Heart failure patients with NYHA class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure in the past 12 months, without stage IV or V chronic kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily heart failure hospitalizations, heart failure related quality of life and re-admissions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

9.3 years

First QC Date

March 31, 2016

Last Update Submit

September 2, 2025

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • Heart Failure Hospitalizations

    Number of admissions to the hospital for the treatment of heart failure

    1 year

Secondary Outcomes (1)

  • Heart Failure Related Quality of Life

    1 year

Other Outcomes (1)

  • Heart Failure Outpatient Visits

    1 year

Interventions

CardiomemsDEVICE

Eligible patients will undergo implantation of a pulmonary artery sensor (CardioMEMS), a wireless implantable hemodynamic monitoring system in the cardiac catheterization laboratory. This system has a passive wireless, radiofrequency sensor without batteries or leads. Patients transmit data through a device in their home that interacts wirelessly with the sensor. Clinicians retrieve this data via a web interface to use in making management decisions for patients.

Eligibility Criteria

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

Patients 18 years or older with New York Heart Association functional class III heart failure for at least three months, irrespective of left ventricular ejection fraction or cause, and a hospitalization for heart failure within the past 12 months who are on optimal medical and device management. Patients being referred for the placement of a Cardiomems device by their clinical Heart Failure Cardiologist will be invited to participate in the registry.

You may qualify if:

  • years of age or older
  • NYHA class III heart failure
  • Heart Failure Hospitalization in the last 12 months
  • Optimal heart failure medical and device therapies per national heart failure guidelines

You may not qualify if:

  • History of recurrent pulmonary embolism or deep vein thrombosis
  • Cardiac resynchronization device placement in the last three months
  • Stage IV or V chronic kidney disease
  • Unable to take anti-platelet or anti-coagulation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011 Feb 19;377(9766):658-66. doi: 10.1016/S0140-6736(11)60101-3.

    PMID: 21315441BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lee R Goldberg, MD, MPH

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)