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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with an implanted Medtronic market approved CRT-D device.
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| Name | Affiliation | Role |
|---|---|---|
| Heart Sounds During CRT Clinical Trial Leader | Medtronic CRDM Clinical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Lo, Inc. | Riverside | California | 92501 | United States | ||
| Orlando Health |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Essentia Institute of Rural Health | Duluth | Minnesota | 55805 | United States |
| Methodist DeBakey Cardiology Associates | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |