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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TREATMENT Group

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

Group Type ACTIVE_COMPARATOR

HF Pressure Measurement System

Intervention Type DEVICE

A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.

CONTROL Group

Standard of care HF management

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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HF Pressure Measurement System

A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No