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

Abbott

Status: Completed

Conditions: Heart Failure, Congestive

Treatments: Device: HF Pressure Measurement System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00531661

CM-06-04

Details and patient eligibility

About

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.

Enrollment: 550 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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550 participants in 2 patient groups, including a placebo group

TREATMENT Group

Active Comparator group

Description:

Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System

Treatment:

Device: HF Pressure Measurement System

CONTROL Group

Placebo Comparator group

Description:

Standard of care HF management