CardioMEMS HF System Post Approval Study

NCT02279888 | Completed Results DMC

• 1 other identifier: SJM-CIP-10035
• Study Type: observational
• Target: 1,214
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Left-Sided Heart Failure; Congestive Heart Failure

Keywords

Pulmonary Artery Pressure Monitoring; Implantable Hemodynamic Monitor

Outcome Measures

Primary Outcomes (3)

• Freedom From Device and/or System Related Complication (DSRC)

  As defined in the study protocol, a DSRC is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

  two years

• Freedom From Pressure Sensor Failure

  A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

  two year

• Heart Failure Hospitalization (HFH) Rate

  Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.

  one year

Other Outcomes (6)

• Overall Survival

  one and two years

• Heart Failure Hospitalization or Death Rate

  one year

• Patient Compliance

  One and Two Years

Study Arms (1)

CardioMEMS HF System Group

Patients implanted with a CardioMEMS HF System.

Device: CardioMEMS HF System

Interventions

CardioMEMS HF System DEVICE

Pulmonary artery pressure sensor

CardioMEMS HF System Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with NYHA class III heart failure

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

West Virginia Heart Institute

Morgantown, West Virginia, 26505, United States

Location

Related Publications (4)

• Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14.

  PMID: 40223608 DERIVED

• 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.

  PMID: 34509410 DERIVED

• 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.

  PMID: 34129363 DERIVED

• 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.

  PMID: 32757642 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Lynne Stevenson
• Organization: Vanderbilt University Medical Center

lynne.w.stevenson@vanderbilt.edu

6159368187

Study Officials

• Lynne Stevenson, MD

  Brigham and Women's

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: January 1, 2015
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: April 17, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Locations

US (1)