Wireless, Intermittent Monitoring of Right Heart Pressures in HF

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

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.

Study Overview

• Status: Completed
• Conditions: NYHA Class III Heart Failure
• Intervention / Treatment: Device: CardioMEMS HF Pressure Measurement System

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30313
      • Piedmont Hospital
  • Ohio
    • Columbus, Ohio, United States, 43085
      • Ohio State University Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37201
      • St Thomas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	after implant of the sensor and at 60 day visit

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	after deployment of the sensor and at 60 days

Collaborators and Investigators

• Sponsor: CardioMEMS

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: July 14, 2010
• First Posted (Estimate): July 15, 2010

Study Record Updates

• Last Update Posted (Estimate): January 19, 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: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CM-06-03