CardioMEMS HF System OUS Post Market Study

The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Congestive Heart Failure; Left-Sided Heart Failure
• Intervention / Treatment: Device: CardioMEMS HF System

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
• Belgium
  • Liège, Belgium
    • CHR Citadelle
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• France
  • Lille, France
    • CHRU de Lille
• United Kingdom
  • London, United Kingdom
    • Royal Bromptom Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a heart failure hospitalization within the past 12 months.

Description

Inclusion Criteria:

1. Written informed consent obtained from subject
2. ≥ 18 years of age
3. Diagnosis of NYHA Class III Heart Failure
4. At least 1 HF hospitalization within 12 months of Baseline visit
5. Subjects 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 subject is intolerant to beta blockers, ACE-I or ARB.
6. Subjects with a BMI ≤ 35. Subjects 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.
7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
8. Subjects willing and able to comply with the follow-up requirements of the study

Exclusion Criteria:

1. Subjects with an active infection
2. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
3. Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
5. Subjects with Cardiac Resynchronization Device (CRT) implanted < 3 months prior to enrollment
6. Subjects with a Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
7. Subjects with congenital heart disease or mechanical right heart valve(s)
8. Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
9. Subjects with known coagulation disorders
10. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from device/system related complications	Two year
Freedom from pressure sensor failure.	Two year
Annualized HF hospitalization rate at 1 year compared to the HF hospitalization rate in the year prior to enrollment.	One year

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Martin R Cowie, MD, Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

General Publications

• Cowie MR, Flett A, Cowburn P, Foley P, Chandrasekaran B, Loke I, Critoph C, Gardner RS, Guha K, Betts TR, Carr-White G, Zaidi A, Lim HS, Hayward C, Patwala A, Rogers D, Pettit S, Gazzola C, Henderson J, Adamson PB. Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study. ESC Heart Fail. 2022 Feb;9(1):48-56. doi: 10.1002/ehf2.13748. Epub 2021 Dec 9.
• Cowie MR, de Groote P, McKenzie S, Brett ME, Adamson PB; CardioMEMS Post-Market Study Investigators. Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST. ESC Heart Fail. 2020 Jun;7(3):865-872. doi: 10.1002/ehf2.12646. Epub 2020 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimated): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SJM-CIP-10147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No