Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal
SonR Pilot
Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 28, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 20, 2012
December 1, 2012
1.5 years
January 28, 2011
December 18, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Optimal blood flow method
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.
3 months
Study Arms (1)
All Patients
OTHERAll patients will have an echocardiogram and SonR sensor readings completed.
Interventions
All patients will have an echocardiograph and SonR sensor readings
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Piedmont Healthcarelead
- LivaNovacollaborator
Study Sites (1)
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Dan, MD
Piedmont Heart Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2011
First Posted
February 1, 2011
Study Start
January 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
December 20, 2012
Record last verified: 2012-12