CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients

Completed · Not applicable

Conditions studied: Heart Failure, Congestive

In brief

This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.

Key facts

Study ID

NCT00531661

Run by

CardioMEMS

People needed

550

Starts

2007-09-01

Expected to finish

2014-11-01

Last updated by the study team

2015-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
• Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
• Subjects with reduced LVEF must 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. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
• At least 1 HF hospitalization within 12 months of Screening Visit
• Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

You may not qualify if…

• Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
• Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
• Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
• Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
• Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
• Subjects likely to undergo heart transplantation within 6 months of Screening Visit
• Subjects with congenital heart disease or mechanical right heart valve(s)
• Subjects with known coagulation disorders
• Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel

Where it is running

• CardioMEMS Investigational Sites — Nationwide, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.