Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01287234

Acronym

SonR Pilot

Enrollment

Registered

2011-02-01

Start date

2011-01-31

Completion date

2012-07-31

Last updated

2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

OTHEREchocardiogram/SonR

All patients will have an echocardiograph and SonR sensor readings

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Optimal blood flow method	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026