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

This study has been completed.
Sponsor:
Collaborator:
Sorin Group
Information provided by (Responsible Party):
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01287234
First received: January 28, 2011
Last updated: December 18, 2012
Last verified: December 2012

January 28, 2011
December 18, 2012
January 2011
July 2012   (final data collection date for primary outcome measure)
Optimal blood flow method [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01287234 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Heart Failure
Other: Echocardiogram/SonR
All patients will have an echocardiograph and SonR sensor readings
All Patients
All patients will have an echocardiogram and SonR sensor readings completed.
Intervention: Other: Echocardiogram/SonR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01287234
SonR Pilot
No
Piedmont Healthcare
Piedmont Healthcare
Sorin Group
Principal Investigator: Dan Dan, MD Piedmont Heart Institute
Piedmont Healthcare
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP