Back to resultsWireless, Intermittent Monitoring of Right Heart Pressures in HF
Primary Purpose
NYHA Class III Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CardioMEMS HF Pressure Measurement System
Sponsored by
About this trial
This is an interventional treatment trial for NYHA Class III Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Subject is male or female, at least 18 years of age
- 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.
- Subject has a diagnosis of New York Heart Association (NYHA) Class III HF at screening and at baseline.
- Subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
- Subject has life expectancy of 1-2 years.
Exclusion Criteria:
- 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.
- Subject is unable to tolerate a right heart catheterization.
- Subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
- Subject has permanent indwelling central venous catheter.
- Subject has history of myocardial infarction (MI), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
- Subject has history of congenital heart disease or prosthetic valve on right side.
- Subject has unstable hypertension.
- Subject has a known coagulability disease state.
- Subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
- Subject has active lung infection or acute pulmonary decompensation.
- Subject has elevated white blood cell count and signs of infection are evident.
- Subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
- Subject who is pregnant or lactating or might become pregnant during the duration of the study.
- Subject who is participating in another therapeutic interventional trial.
- 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.
Sites / Locations
- Piedmont Hospital
- Ohio State University Hospital
- Oklahoma Heart Hospital
- St Thomas Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pressure Measurement System
Arm Description
CardioMEMS HF Pressure Measurement System
Outcomes
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01162707
Brief Title
Wireless, Intermittent Monitoring of Right Heart Pressures in HF
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioMEMS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NYHA Class III Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pressure Measurement System
Arm Type
Experimental
Arm Description
CardioMEMS HF Pressure Measurement System
Intervention Type
Device
Intervention Name(s)
CardioMEMS HF Pressure Measurement System
Intervention Description
Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
after implant of the sensor and at 60 day visit
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male or female, at least 18 years of age
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.
Subject has a diagnosis of New York Heart Association (NYHA) Class III HF at screening and at baseline.
Subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
Subject has life expectancy of 1-2 years.
Exclusion Criteria:
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.
Subject is unable to tolerate a right heart catheterization.
Subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
Subject has permanent indwelling central venous catheter.
Subject has history of myocardial infarction (MI), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
Subject has history of congenital heart disease or prosthetic valve on right side.
Subject has unstable hypertension.
Subject has a known coagulability disease state.
Subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
Subject has active lung infection or acute pulmonary decompensation.
Subject has elevated white blood cell count and signs of infection are evident.
Subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
Subject who is pregnant or lactating or might become pregnant during the duration of the study.
Subject who is participating in another therapeutic interventional trial.
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.
Facility Information:
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30313
Country
United States
Facility Name
Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43085
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
St Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37201
Country
United States
12. IPD Sharing Statement
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Wireless, Intermittent Monitoring of Right Heart Pressures in HF
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