MedTrace Logo

Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal

NCT00604903 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-02-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate and document appropriate clinical safety and performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated application software. It is a small clinical trial to determine the feasibility of the device. The primary outcome measure relates to feasibility and not to health outcomes.

Conditions

Interventions

DEVICE

Implant of Pressure sensor.

Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Horst Sievert, M.D. · CardioVascular Center Frankfurt, Seckbacher

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-23
Primary Completion
2009-02-28
Completion
2009-02-28

More Related Trials

Entities

Diseases

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 NCT00604903 on ClinicalTrials.gov