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

Study Overview
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Brief Summary
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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.

Official Title
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Cutaneous Heart Sounds Data Collection During CRT Optimization Study

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors. | 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. | A two hour office visit within two years of CRT-Defibrillator (D) and lead system implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of modified Virtuoso® Implantable Cardiac Defibrillator (ICD) heart sounds and CRT-D electrogram (EGM) vectors | 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. | A two hour office visit within two years of CRT-D and lead system implant | 
| Determine if modified Virtuoso® ICD recorded heart sounds and CRT-D recorded EGM are able to detect phrenic nerve stimulation (PNS) |  | A two hour office visit within two years of CRT-D and lead system implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices