CompletedNot Applicable

CardioMEMS HF System OUS Post Market Study

Australia, Belgium, Denmark321 participantsStarted 2016-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Freedom From Device/System Related Complications

Timeframe: Two year

Freedom From Pressure Sensor Failure.

Timeframe: Two year

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

Timeframe: One year

Trial details

NCT IDNCT02954341

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-08

Results submitted2024-11-09

View on ClinicalTrials.gov More Heart Failure trials