We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01287234
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : December 20, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure Other: Echocardiogram/SonR

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study
Study Start Date : January 2011
Primary Completion Date : July 2012
Study Completion Date : July 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287234


Locations
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
LivaNova
Investigators
Principal Investigator: Dan Dan, MD Piedmont Heart Institute
More Information

Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT01287234     History of Changes
Other Study ID Numbers: SonR Pilot
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases