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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02954341




Registration number
NCT02954341
Ethics application status
Date submitted
21/10/2016
Date registered
3/11/2016
Date last updated
8/01/2021

Titles & IDs
Public title
CardioMEMS HF System OUS Post Market Study
Scientific title
CardioMEMS HF System OUS Post Market Study
Secondary ID [1] 0 0
SJM-CIP-10147
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Left-Sided Heart Failure 0 0
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - CardioMEMS HF System

Treatment: Devices: CardioMEMS HF System


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from device/system related complications
Timepoint [1] 0 0
Two year
Primary outcome [2] 0 0
Freedom from pressure sensor failure.
Timepoint [2] 0 0
Two year
Primary outcome [3] 0 0
Annualized HF hospitalization rate at 1 year compared to the HF hospitalization rate in the year prior to enrollment.
Timepoint [3] 0 0
One year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Liège
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
France
State/province [3] 0 0
Lille
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02954341
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin R Cowie, MD
Address 0 0
Royal Brompton & Harefield NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maxime De Groof
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
maxime.degroof@abbott.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02954341