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Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device

NCT00957541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2014-05-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

Paradym CRT + Physiological Diagnosis (PhD)

All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Sponsors & Collaborators

  • LivaNova

    collaborator INDUSTRY

  • ELA Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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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 NCT00957541 on ClinicalTrials.gov