NYHA Class III Heart FailureNCT01162707
Wireless, Intermittent Monitoring of Right Heart Pressures in HF
A study testing CardioMEMS HF Pressure Measurement System in people with NYHA Class III Heart Failure, run by CardioMEMS at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NYHA Class III Heart Failure
- What is being tested?
- CardioMEMS HF Pressure Measurement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2006to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Piedmont Hospital
Atlanta, Georgia, 30313
Ohio State University Hospital
Columbus, Ohio, 43085
St Thomas Hospital
Nashville, Tennessee, 37201
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
About this study
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
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.
Read the 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.
- Conditions
- NYHA Class III Heart Failure
- Being tested
- CardioMEMS HF Pressure Measurement System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMEMS HF Pressure Measurement SystemDevice
Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure
| Study group | Role | What they receive |
|---|---|---|
| Pressure Measurement System | Experimental | CardioMEMS HF Pressure Measurement System Receives: Device: CardioMEMS HF Pressure Measurement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after deployment of the sensor and at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startDec 2006
- Primary completionNov 2007
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NYHA Class III Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioMEMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162707
- Sponsor's protocol ID
- CM-06-03
- Status last verified
- Jan 2015
- First submitted
- 13 Jul 2010
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01162707
- Acronym / sponsor ID
- CM-06-03
- Conditions
- NYHA Class III Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- CardioMEMSIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure Measurement System | Experimental | Device: CardioMEMS HF Pressure Measurement SystemCardioMEMS HF Pressure Measurement System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioMEMS HF Pressure Measurement SystemImplant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure | Device | Pressure Measurement System |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioMEMS HF Pressure Measurement System in people with NYHA Class III Heart Failure, run by CardioMEMS at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.