Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:March 2012
End Date:June 2012
Contact:Heart Sounds During CRT Study Team
Email:medtronicCRMtrials@medtronic.com

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Cutaneous Heart Sounds Data Collection During CRT Optimization Study


The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute,
prospective, non-randomized multi-center feasibility clinical trial. The purpose of this
clinical trial is to collect data to assist in the testing and finalization of a hemodynamic
sensor-based cardiac resynchronization therapy (CRT) optimization scheme.


Inclusion Criteria:

- Subject must have been implanted with a Medtronic market approved CRT-D device
(Concerto®, Concerto® II, Maximo® II, Consulta®, Protecta™, or Protecta™ XT) within
two years

- Subject must be 18 years of age or older

- Subject or his/her legally authorized representative has signed and dated the study
specific informed consent form ("Consent Form")

- Subject is willing and able to comply with protocol requirements

Exclusion Criteria:

- Subject with atrial tachyarrhythmia or frequent atrial or ventricular ectopy

- Subject is post mitral or aortic valve repair or replacement

- Subject is participating in other research studies that many confound the results of
this study

- Subject is pregnant or in fertile age without secure birth control

- Subject has dementia

- Subject is unwilling to comply with protocol requirements

- Subject has a device and lead system with fractured leads

- Subject cannot undergo an echocardiograph procedure, or is contraindicated to undergo
such a procedure
We found this trial at
5
sites
Duluth, Minnesota 55805
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24 Sturtevant St
Orlando, Florida 32806
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Orlando, FL
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Houston, TX
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Riverside, California 92501
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Riverside, CA
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