N/A
N=550
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT00531661 ↗Enrolled (actual)
550
Serious AEs
50.2%
Results posted
Apr 2013
Primary outcome: Primary: Rate of Heart Failure Related (HFR) Hospitalizations — 0.32; 0.44 HFR hospitalizations/patient/6 months — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HF Pressure Measurement System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CardioMEMS
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Heart Failure Related (HFR) Hospitalizations |
0.32; 0.44 | 0.0002 sig |
| PRIMARY Freedom From a Device/System-related Complication (DSRC). |
567 | <0.0001 sig |
| PRIMARY Freedom From Pressure Sensor Failure |
498 | <0.0001 sig |
| SECONDARY Change From Baseline in Pulmonary Artery Mean Pressure |
-155.7; 33.1 | 0.0077 sig |
| SECONDARY Proportion of Patients Hospitalized for Heart Failure |
55; 80 | 0.0292 sig |
| SECONDARY Days Alive Outside of the Hospital |
174.4; 172.1 | 0.0280 sig |
| SECONDARY Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ) |
45.2; 50.6 | 0.0236 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00531661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.