Clinical trial NCT02279888: CardioMEMS HF System Post Approval Study
Official title: CardioMEMS HF System Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Left-Sided Heart Failure
Congestive Heart Failure
Keywords: Pulmonary Artery Pressure Monitoring
Implantable Hemodynamic Monitor
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 1214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with NYHA class III heart failure

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom From Device and/or System Related Complication (DSRC)
timeFrame: two years
measure: Freedom From Pressure Sensor Failure
timeFrame: two year
measure: Heart Failure Hospitalization (HFH) Rate
timeFrame: one year
Secondary outcomes:
Other outcomes:
measure: Overall Survival
timeFrame: one and two years
measure: Heart Failure Hospitalization or Death Rate
timeFrame: one year
measure: Patient Compliance
timeFrame: One and Two Years
measure: Training Evaluation - Freedom From DRSC in Academic and Community Hospitals
timeFrame: 2 Years
measure: Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals
timeFrame: 2 Years
measure: Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals
timeFrame: 2 Years
Locations:
city: Morgantown
country: United States
facility: West Virginia Heart Institute
state: West Virginia
Study officials:
affiliation: Brigham and Women's
name: Lynne Stevenson, MD
role: STUDY_CHAIR
References:
citation: Brinkley DM, Guglin ME, Bennett MK, Redfield MM, Abraham WT, Brett ME, Dirckx N, Adamson PB, Stevenson LW. Pulmonary Artery Pressure Monitoring Effectively Guides Management to Reduce Heart Failure Hospitalizations in Obesity. JACC Heart Fail. 2021 Nov;9(11):784-794. doi: 10.1016/j.jchf.2021.05.020. Epub 2021 Sep 8.
citation: DeFilippis EM, Henderson J, Axsom KM, Costanzo MR, Adamson PB, Miller AB, Brett ME, Givertz MM. Remote Hemodynamic Monitoring Equally Reduces Heart Failure Hospitalizations in Women and Men in Clinical Practice: A Sex-Specific Analysis of the CardioMEMS Post-Approval Study. Circ Heart Fail. 2021 Jun;14(6):e007892. doi: 10.1161/CIRCHEARTFAILURE.120.007892. Epub 2021 Jun 15.
citation: Shavelle DM, Desai AS, Abraham WT, Bourge RC, Raval N, Rathman LD, Heywood JT, Jermyn RA, Pelzel J, Jonsson OT, Costanzo MR, Henderson JD, Brett ME, Adamson PB, Stevenson LW; CardioMEMS Post-Approval Study Investigators. Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study. Circ Heart Fail. 2020 Aug;13(8):e006863. doi: 10.1161/CIRCHEARTFAILURE.119.006863. Epub 2020 Aug 6.