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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
History of Changes
  Purpose

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 Intervention
Heart Failure
 Other: Echocardiogram/SonR

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287234

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

No publications provided

Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT01287234     History of Changes
Other Study ID Numbers: SonR Pilot
Study First Received: January 28, 2011
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013