An After Approval Study of the CardioMEMS Heart Failure System

Overview

About this study

The purpose of the CardioMEMS HF System post approval study is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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) and non-responsive to diuretic therapy or 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Brian Hardaway, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Brian Hardaway, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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