MedTrace Logo

Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

NCT01128166 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 975

Last updated 2015-10-21

No results posted yet for this study

Summary

The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.

Conditions

Interventions

DEVICE

COGNIS CRT-D

Patients with existing or newly implanted COGNIS® CRT-D pulse generators (PG)are enrolled in the study. PG is modified by the download of investigational software called Sensor Research Device-1™ (SRD-1). The goal of the SRD-1 system is to collect sensor data without affecting the delivered CRT-D therapy. This is accomplished through the "conversion" of an implanted COGNIS PG into a SRD-1 PG by downloading investigational software. Only a market approved COGNIS model N119/N120/P107/P108 device may be converted to a SRD-1 investigational device. There will be no PG hardware changes resulting from the conversion.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • John P Boehmer, M.D. · Milton S Hershey Medical Center, Hershey, Pennsylvania, United States

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-12-31
Completion
2015-07-31

Countries

  • United States
  • Czechia
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Slovakia
  • Thailand
  • United Kingdom

Study Locations

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 NCT01128166 on ClinicalTrials.gov