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

Sponsor
Piedmont Healthcare (Other)
Overall Status
Completed
CT.gov ID
NCT01287234
Collaborator
LivaNova (Industry)
15
Enrollment
1
Location
1
Arm
18
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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 Phase
  • Other: Echocardiogram/SonR
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
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 :
Jan 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Optimal blood flow method [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Piedmont Heart Institute Atlanta Georgia United States 30309

Sponsors and Collaborators

  • Piedmont Healthcare
  • LivaNova

Investigators

  • Principal Investigator: Dan Dan, MD, Piedmont Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01287234
Other Study ID Numbers:
  • SonR Pilot
First Posted:
Feb 1, 2011
Last Update Posted:
Dec 20, 2012
Last Verified:
Dec 1, 2012
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Dec 20, 2012