CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients

Study Overview
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Brief Summary
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This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.

Official Title
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CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: HF Pressure Measurement System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF Diagnosis of NYHA Class III HF (historical assessment documented at screening visit) Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry. At least 1 HF hospitalization within 12 months of Screening Visit Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel) Exclusion Criteria: Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis Subjects likely to undergo heart transplantation within 6 months of Screening Visit Subjects with congenital heart disease or mechanical right heart valve(s) Subjects with known coagulation disorders Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TREATMENT Group<br>Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System | Device: HF Pressure Measurement System<br>* A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.<br>|
| Placebo Comparator: CONTROL Group<br>Standard of care HF management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Heart Failure Related (HFR) Hospitalizations |  | 6 months | 
| Freedom From a Device/System-related Complication (DSRC). | A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following: is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes) results in the death of the subject results in the explant of the device | 6 months | 
| Freedom From Pressure Sensor Failure | A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pulmonary Artery Mean Pressure | Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days. | 6 months | 
| Proportion of Patients Hospitalized for Heart Failure |  | 6 months | 
| Days Alive Outside of the Hospital |  | 6 months | 
| Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ) | THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life. | 6 months |