CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients - Full Text View

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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by CardioMEMS. Recruitment status was Active, not recruiting

First Received on September 18, 2007. Last Updated on February 5, 2010 History of Changes

Sponsor:	CardioMEMS
Information provided by:	CardioMEMS
ClinicalTrials.gov Identifier:	NCT00531661

Purpose

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.

Condition	Intervention
Heart Failure, Congestive	Device: HF Pressure Measurement System

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic
Official Title:	CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by CardioMEMS:

Primary Outcome Measures:

The primary hypothesis is that the TREATMENT group will have a significantly lower rate of HF-related hospitalizations than the CONTROL group. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	550
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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.
Sham Comparator: 2 CONTROL group: standard of care HF management	Device: HF Pressure Measurement System A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Contact sponsor for details.

Exclusion Criteria:

Contact sponsor for details.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531661

Locations

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

Sponsors and Collaborators

CardioMEMS

Investigators

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Susan Neville, Clinical Project Manager, CardioMEMS, Inc.
ClinicalTrials.gov Identifier:	NCT00531661 History of Changes
Other Study ID Numbers:	CM-06-04
Study First Received:	September 18, 2007
Last Updated:	February 5, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012