CardioMEMS HF System OUS Post Market Study

NCT02954341 | Completed Results

• 1 other identifier: SJM-CIP-10147
• Study Type: observational
• Target: 321
• Locations: 5 countries
• Sites: 5

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Freedom From Device/System Related Complications

  A device/System related complication (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: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device.

  Two year

• 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.

  Two year

• Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.

  HFH events at 1 year versus the HFH events in the year prior to enrollment

  One year

Interventions

CardioMEMS HF System DEVICE

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

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

You may qualify if:

• Written informed consent obtained from subject
• ≥ 18 years of age
• Diagnosis of NYHA Class III Heart Failure
• At least 1 HF hospitalization within 12 months of Baseline visit
• 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.
• 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.
• Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
• Subjects willing and able to comply with the follow-up requirements of the study

You may not qualify if:

• Subjects with an active infection
• Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis
• Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
• Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
• Subjects with Cardiac Resynchronization Device (CRT) implanted \< 3 months prior to enrollment
• 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
• Subjects with congenital heart disease or mechanical right heart valve(s)
• Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
• Subjects with known coagulation disorders
• 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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

CHR Citadelle

Liège, Belgium

Location

Rigshospitalet

Copenhagen, Denmark

Location

CHRU de Lille

Lille, France

Location

Royal Bromptom Hospital

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34882989 DERIVED

• 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.

  PMID: 32031758 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Pascal De Groote
• Organization: CHU de Lille - Institut Coeur Poumon

Pascal.DEGROOTE@chu-lille.fr

33 (0)3 20 44 50 38

Study Officials

• Pascal De Groote, MD

  CHU de Lille - Institut Coeur Poumon

  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 21, 2016
• First Posted: November 3, 2016
• Study Start: July 1, 2016
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DK (1); FR (1); BE (1); GB (1)