Cardiac Resynchronization Therapy (CRT) Efficacy Study

Medtronic Cardiac Rhythm and Heart Failure1 site in 1 country9 target enrollmentDecember 1, 2008

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Enrollment: 9
Locations: 1
Primary Endpoint: classified
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this research study is the invasive evaluation of CR therapy efficacy in patients treated with an InSync Sentry device using an external monitoring device to obtain important cardiac parameters.

Registry

clinicaltrials.gov

Start Date

December 1, 2008

End Date

March 1, 2013

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient indicated for InSync Sentry CRT device implant
•The patient must be willing and capable of following the study protocol
•Systolic pulmonary artery pressure derived by echocardiography \> 40
•Patients with their device functioning in a bi-ventricular mode, with defibrillation detection and therapy enabled
•Marked released transvenous RVCoil lead

Exclusion Criteria

•Patients with chronic AF
•Patients with unipolar atrial or unipolar right ventricular leads
•Patients needing a Lower Rate faster than 110 beats per minute
•Patients with an implanted Medtronic Sentry in whom missing one day's fluid-measurement value is undesirable
•Patients who cannot tolerate turning off Rate Response during the study
•Patients with acute ischemia
•Patients whose InSync Sentry battery is at ERI or EOL status
•Patients with "RAMware" downloaded from other studies
•Patients with medical conditions that would limit study participation
•Patients who are pregnant