CardioMEMS HF System Post Approval Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-10-11

Brief Summary

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The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

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Detailed Description

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The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.

Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.

Conditions

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Heart Failure Left-Sided Heart Failure Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CardioMEMS HF System Group

Patients implanted with a CardioMEMS HF System.

CardioMEMS HF System

Intervention Type DEVICE

Pulmonary artery pressure sensor

Interventions

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CardioMEMS HF System

Pulmonary artery pressure sensor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of NYHA class III heart failure
* At least 1 heart failure hospitalization within previous 12 months
* Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
* BMI ≤ 35. Patients with BMI \>35 will require their chest circumference to be measured at the axillary level. If \> 65 inches the patient will not be eligible for the study.
* Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria

* Active infection
* History of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
* Inability to tolerate a right heart catheterization
* A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
* Cardiac resynchronization device (CRT) implanted within previous 3 months
* Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
* Congenital heart disease or mechanical right heart valve
* Likely to undergo heart transplantation or VAD within the next 6 months
* Known coagulation disorders
* Hypersensitivity or allergy to aspirin, and/or clopidogrel

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No