Wireless, Intermittent Monitoring of Right Heart Pressures in HF

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by CardioMEMS.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
CardioMEMS
ClinicalTrials.gov Identifier:
NCT01162707
First received: July 13, 2010
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

The purpose of the trial is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with NYHA Class III Heart Failure.


Condition Intervention
NYHA Class III Heart Failure
Device: CardioMEMS HF Pressure Measurement System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Non-Randomized, Prospective Trial to Evaluate the Safety and Feasibility of Wireless, Intermittent Monitoring of Right Heart Pressures in Adult Heart Failure Subjects

Resource links provided by NLM:


Further study details as provided by CardioMEMS:

Primary Outcome Measures:
  • The primary objective is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with Class III Heart Failure. [ Time Frame: after implant of the sensor and at 60 day visit ] [ Designated as safety issue: Yes ]
    The trial will demonstrate that the CardioMEMS Sensor can be positioned in the right or left pulmonary artery, and the Sensor pulmonary artery pressure measurements correlate to standardized methods of intra-cardiac pressure measurements immediately after deployment of the sensor and at the 60 day follow-up visit. Safety is assessed by monitoring the occurrence of adverse events.


Secondary Outcome Measures:
  • To demonstrate the capability of the CardioMEMS HF System to obtain the pressure measurement from the Sensor and transmit the pulmonary artery pressure data to a secure database. [ Time Frame: after deployment of the sensor and at 60 days ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: December 2006
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pressure Measurement System
CardioMEMS HF Pressure Measurement System
Device: CardioMEMS HF Pressure Measurement System
Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure

Detailed Description:

The trial is designed to demonstrate that the CardioMEMS Sensor can be positioned in the right or left pulmonary artery, and that Sensor pressure measurements correlate to standardized methods of intra-cardiac pressure measurements post-sensor implant and at the 60 day visit. Safety will be monitored by the occurrence of adverse events throughout the trial.

  Eligibility

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

Inclusion Criteria:

  1. Subject is male or female, at least 18 years of age
  2. Subjects of childbearing age who have a negative serum pregnancy test, and at screening have agreed to use a reliable mechanical or hormonal form of conception during the study.
  3. Subject has a diagnosis of New York Heart Association (NYHA) Class III HF at screening and at baseline.
  4. Subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
  5. Subject has life expectancy of 1-2 years.

Exclusion Criteria:

  1. Subject has unstable medical condition or impairment other than a medical condition associated with HF which would significantly increase the subject's morbidity or mortality risk.
  2. Subject is unable to tolerate a right heart catheterization.
  3. Subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
  4. Subject has permanent indwelling central venous catheter.
  5. Subject has history of myocardial infarction (MI), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
  6. Subject has history of congenital heart disease or prosthetic valve on right side.
  7. Subject has unstable hypertension.
  8. Subject has a known coagulability disease state.
  9. Subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
  10. Subject has active lung infection or acute pulmonary decompensation.
  11. Subject has elevated white blood cell count and signs of infection are evident.
  12. Subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
  13. Subject who is pregnant or lactating or might become pregnant during the duration of the study.
  14. Subject who is participating in another therapeutic interventional trial.
  15. Subject has other medical, psychological, or social circumstances that may affect the ability to comply with the study requirements or increase risk to the subject.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162707

Locations
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30313
United States, Ohio
Ohio State University Hospital
Columbus, Ohio, United States, 43085
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Tennessee
St Thomas Hospital
Nashville, Tennessee, United States, 37201
Sponsors and Collaborators
CardioMEMS
  More Information

No publications provided

Responsible Party: CardioMEMS
ClinicalTrials.gov Identifier: NCT01162707     History of Changes
Other Study ID Numbers: CM-06-03
Study First Received: July 13, 2010
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014