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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No