NCT00531661

Brief Summary

This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

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

September 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 9, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

September 18, 2007

Results QC Date

November 16, 2012

Last Update Submit

January 16, 2015

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (3)

  • Rate of Heart Failure Related (HFR) Hospitalizations

    6 months

  • Freedom From a Device/System-related Complication (DSRC).

    A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following: * is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes) * results in the death of the subject * results in the explant of the device

    6 months

  • Freedom From Pressure Sensor Failure

    A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.

    6 months

Secondary Outcomes (4)

  • Change From Baseline in Pulmonary Artery Mean Pressure

    6 months

  • Proportion of Patients Hospitalized for Heart Failure

    6 months

  • Days Alive Outside of the Hospital

    6 months

  • Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)

    6 months

Other Outcomes (3)

  • Rate of HFR Hospitalizations

    Study duration: average patient follow-up of 15 months

  • Freedom From a Device/System-related Complication (DSRC)

    Study duration: average patient follow-up of 15 months

  • Freedom From Pressure Sensor Failure

    Study duration: average patient follow-up of 15 months

Study Arms (2)

TREATMENT Group

ACTIVE COMPARATOR

Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System

Device: HF Pressure Measurement System

CONTROL Group

PLACEBO COMPARATOR

Standard of care HF management

Interventions

HF Pressure Measurement SystemDEVICE

A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.

TREATMENT Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
  • Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
  • Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
  • At least 1 HF hospitalization within 12 months of Screening Visit
  • Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

You may not qualify if:

  • Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
  • Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
  • Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
  • Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
  • Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  • Subjects likely to undergo heart transplantation within 6 months of Screening Visit
  • Subjects with congenital heart disease or mechanical right heart valve(s)
  • Subjects with known coagulation disorders
  • Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CardioMEMS Investigational Sites

Nationwide, Georgia, 30313, United States

Location

Related Publications (8)

  • Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.

    PMID: 40223608DERIVED

  • Varma N, Bourge RC, Stevenson LW, Costanzo MR, Shavelle D, Adamson PB, Ginn G, Henderson J, Abraham WT; CHAMPION Investigator Group. Remote Hemodynamic-Guided Therapy of Patients With Recurrent Heart Failure Following Cardiac Resynchronization Therapy. J Am Heart Assoc. 2021 Feb;10(5):e017619. doi: 10.1161/JAHA.120.017619. Epub 2021 Feb 25.

    PMID: 33626889DERIVED

  • Givertz MM, Stevenson LW, Costanzo MR, Bourge RC, Bauman JG, Ginn G, Abraham WT; CHAMPION Trial Investigators. Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2017 Oct 10;70(15):1875-1886. doi: 10.1016/j.jacc.2017.08.010.

    PMID: 28982501DERIVED

  • Adamson PB, Abraham WT, Stevenson LW, Desai AS, Lindenfeld J, Bourge RC, Bauman J. Pulmonary Artery Pressure-Guided Heart Failure Management Reduces 30-Day Readmissions. Circ Heart Fail. 2016 Jun;9(6):e002600. doi: 10.1161/CIRCHEARTFAILURE.115.002600.

    PMID: 27220593DERIVED

  • Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.

    PMID: 26560249DERIVED

  • Raina A, Abraham WT, Adamson PB, Bauman J, Benza RL. Limitations of right heart catheterization in the diagnosis and risk stratification of patients with pulmonary hypertension related to left heart disease: insights from a wireless pulmonary artery pressure monitoring system. J Heart Lung Transplant. 2015 Mar;34(3):438-47. doi: 10.1016/j.healun.2015.01.983. Epub 2015 Feb 7.

    PMID: 25813770DERIVED

  • Adamson PB, Abraham WT, Bourge RC, Costanzo MR, Hasan A, Yadav C, Henderson J, Cowart P, Stevenson LW. Wireless pulmonary artery pressure monitoring guides management to reduce decompensation in heart failure with preserved ejection fraction. Circ Heart Fail. 2014 Nov;7(6):935-44. doi: 10.1161/CIRCHEARTFAILURE.113.001229. Epub 2014 Oct 6.

    PMID: 25286913DERIVED

  • 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: 21315441DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Jordan Bauman
Organization
CardioMEMS, Inc.
jbauman@cardiomems.com
4043458235

Study Officials

  • Phillip Adamson, MD, FACC

    Oklahoma Heart Hospital

    PRINCIPAL INVESTIGATOR

  • William T Abraham, MD, FACC

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2007

First Posted

September 19, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2010

Study Completion

November 1, 2014

Last Updated

January 28, 2015

Results First Posted

April 9, 2013

Record last verified: 2015-01

Locations

US(1)