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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Echocardiogram/SonR

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All Patients; All patients will have an echocardiogram and SonR sensor readings completed.	Other: Echocardiogram/SonR; All patients will have an echocardiograph and SonR sensor readings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal blood flow method	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.	3 months

Collaborators and Investigators

• Sponsor: Piedmont Healthcare
• Collaborators: LivaNova
• Investigators: Principal Investigator: Dan Dan, MD, Piedmont Heart Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: January 29, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 18, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SonR Pilot