Wireless, Intermittent Monitoring of Right Heart Pressures in HF

NCT01162707 | Completed DMC

• 1 other identifier: CM-06-03
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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.

Conditions

NYHA Class III Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Pressure Measurement System

EXPERIMENTAL

CardioMEMS HF Pressure Measurement System

Device: CardioMEMS HF Pressure Measurement System

Interventions

CardioMEMS HF Pressure Measurement System DEVICE

Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure

Pressure Measurement System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CardioMEMS: lead

Study Sites (4)

Piedmont Hospital

Atlanta, Georgia, 30313, United States

Location

Ohio State University Hospital

Columbus, Ohio, 43085, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

St Thomas Hospital

Nashville, Tennessee, 37201, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: December 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: September 1, 2012
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

US (4)