Overview

This trial is active, not recruiting.

Condition heart failure, congestive
Treatment hf pressure measurement system
Sponsor CardioMEMS
Start date September 2007
End date May 2010
Trial size 550 participants
Trial identifier NCT00531661, CM-06-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
hf pressure measurement system
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
(Placebo Comparator)
Standard of care HF management

Primary Outcomes

Measure
Rate of Heart Failure Related (HFR) Hospitalizations
time frame: 6 months
Freedom From a Device/System-related Complication (DSRC).
time frame: 6 months
Freedom From Pressure Sensor Failure
time frame: 6 months

Secondary Outcomes

Measure
Change From Baseline in Pulmonary Artery Mean Pressure
time frame: 6 months
Proportion of Patients Hospitalized for Heart Failure
time frame: 6 months
Days Alive Outside of the Hospital
time frame: 6 months
Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF 2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit) 3. 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. 4. At least 1 HF hospitalization within 12 months of Screening Visit 5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel) Exclusion Criteria: 1. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis 2. Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization 3. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit 4. Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment 5. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis 6. Subjects likely to undergo heart transplantation within 6 months of Screening Visit 7. Subjects with congenital heart disease or mechanical right heart valve(s) 8. Subjects with known coagulation disorders 9. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel

Additional Information

Official title CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Principal investigator Phillip Adamson, MD, FACC
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by CardioMEMS.