Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study

Piedmont Healthcare1 site in 1 country15 target enrollmentJanuary 2011

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Piedmont Healthcare
Enrollment: 15
Locations: 1
Primary Endpoint: Optimal blood flow method
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

July 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Piedmont Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization
•≥18 years of age
•Ability and willingness to provide written informed consent and HIPAA authorization

Exclusion Criteria

•Chronic Atrial Fibrillation
•Heart Failure decompensation event within two weeks of enrollment
•Hypertrophic Obstructive Cardiomyopathy
•Patient currently enrolled in another ongoing clinical trial
•Pregnancy
•Less than 18 years of age
•Inability or unwillingness to provide written informed consent and HIPAA authorization

Outcomes

Primary Outcomes

Optimal blood flow method

Time Frame: 3 months

To determine the best method of timing the contractions of the top and bottom chambers of the heart by using echocardiography versus using signals of the external SonR sensor.