Clinical trial NCT02954341: CardioMEMS HF System OUS Post Market Study
Official title: CardioMEMS HF System OUS Post Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Left-Sided Heart Failure
Congestive Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 321
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: Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a heart failure hospitalization within the past 12 months.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Freedom From Device/System Related Complications
timeFrame: Two year
measure: Freedom From Pressure Sensor Failure.
timeFrame: Two year
measure: Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Liège
country: Belgium
facility: CHR Citadelle
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Lille
country: France
facility: CHRU de Lille
city: London
country: United Kingdom
facility: Royal Bromptom Hospital
Study officials:
affiliation: CHU de Lille - Institut Coeur Poumon
name: Pascal De Groote, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.