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

NCT00531661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2015-01-28

Study results available
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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.

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

HF Pressure Measurement System

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

Sponsors & Collaborators

  • CardioMEMS

    lead INDUSTRY

Principal Investigators

  • Phillip Adamson, MD, FACC · Oklahoma Heart Hospital

  • William T Abraham, MD, FACC · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-05-31
Completion
2014-11-30

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531661 on ClinicalTrials.gov