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Completed

NCT Number: NCT01287234

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiogram/SonR

Other

All patients will have an echocardiograph and SonR sensor readings

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Piedmont Healthcare

Other

Collaborators

  • LivaNova

Registry information

Official study title

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

Acronym: SonR Pilot

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2011
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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