NCT02954341Completed
CardioMEMS HF System OUS Post Market Study
Source: ClinicalTrials.gov · Last updated 24 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 321 (actual)
- First submitted
- 21 Oct 2016
- Start date
- Jul 2016
- Primary completion date
- 8 Dec 2023
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Heart failure
- NCT number
- NCT02954341
What you commit to
- Study type: Observational
- Participants enrolled: 321
- From Jul 2016 to the primary completion date, 8 Dec 2023
- 5 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with Cardiac Resynchronization Device (CRT) implanted \< 3 months prior to enrollment
Other illness
- 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 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
Lab values
- 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 a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Prince Charles Hospital Coordinator of this site? Confirm its status | Chermside | Australia | Unknown status |
| CHR Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| CHRU de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Royal Bromptom Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.