CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION)

January 16, 2015 updated by: CardioMEMS
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Nationwide, Georgia, United States, 30313
        • CardioMEMS Investigational Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
  2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
  3. 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.
  4. At least 1 HF hospitalization within 12 months of Screening Visit
  5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TREATMENT Group
Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
Device: HF Pressure Measurement System
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
PLACEBO_COMPARATOR: CONTROL Group
Standard of care HF management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Heart Failure Related (HFR) Hospitalizations
Time Frame: 6 months
6 months
Freedom From a Device/System-related Complication (DSRC).
Time Frame: 6 months

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
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pulmonary Artery Mean Pressure
Time Frame: 6 months
Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.
6 months
Proportion of Patients Hospitalized for Heart Failure
Time Frame: 6 months
6 months
Days Alive Outside of the Hospital
Time Frame: 6 months
6 months
Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Time Frame: 6 months
THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Rate of HFR Hospitalizations
Time Frame: Study duration: average patient follow-up of 15 months
Study duration: average patient follow-up of 15 months
Freedom From a Device/System-related Complication (DSRC)
Time Frame: Study duration: average patient follow-up of 15 months
Study duration: average patient follow-up of 15 months
Freedom From Pressure Sensor Failure
Time Frame: Study duration: average patient follow-up of 15 months
Study duration: average patient follow-up of 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioMEMS

Investigators

  • Principal Investigator: Phillip Adamson, MD, FACC, Oklahoma Heart Hospital
  • Principal Investigator: William T Abraham, MD, FACC, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (ESTIMATE)

September 19, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM-06-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe