Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
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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.
Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors. [ Time Frame: A two hour office visit within two years of CRT-Defibrillator (D) and lead system implant ]
The cardiac signals collected by the modified Virtuoso® ICD and implanted CRT-D EGM vectors will be used to determine how to improve and finalize a prototyped hemodynamic sensor-based CRT optimization scheme.
Secondary Outcome Measures
Comparison of modified Virtuoso® Implantable Cardiac Defibrillator (ICD) heart sounds and CRT-D electrogram (EGM) vectors [ Time Frame: A two hour office visit within two years of CRT-D and lead system implant ]
The heart sounds vector data from the externally affixed modified Virtuoso® ICD will be compared to the EGM vectors from the implanted CRT-D device after CRT optimization.
Determine if modified Virtuoso® ICD recorded heart sounds and CRT-D recorded EGM are able to detect phrenic nerve stimulation (PNS) [ Time Frame: A two hour office visit within two years of CRT-D and lead system implant ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with an implanted Medtronic market approved CRT-D device.
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
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