Wireless, Intermittent Monitoring of Right Heart Pressures in HF

• Sponsor: CardioMEMS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01162707
• Collaborator: (none)
• Enrollment: 17
• Locations: 4
• Arm: 1
• Duration (Months): 69
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
NYHA Class III Heart Failure	Device: CardioMEMS HF Pressure Measurement System	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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. [after implant of the sensor and at 60 day visit]

   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

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Piedmont Hospital	Atlanta	Georgia	United States	30313
2	Ohio State University Hospital	Columbus	Ohio	United States	43085
3	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73120
4	St Thomas Hospital	Nashville	Tennessee	United States	37201

Sponsors and Collaborators

• CardioMEMS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CardioMEMS
• ClinicalTrials.gov Identifier: NCT01162707
• Other Study ID Numbers: CM-06-03
• First Posted: Jul 15, 2010
• Last Update Posted: Jan 19, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jan 19, 2015