An After Approval Study of the CardioMEMS Heart Failure System
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-000124
NCT ID: NCT02279888
Sponsor Protocol Number: CIP-10035
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 |
|
More information
Publications
Publications are currently not available