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 |
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
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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