Heart Failure Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

52

Study ID:

NCT01609985

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 5 Locations for this study

See Locations Near You

Ronald Lo, Inc.
Riverside California, 92501, United States
Orlando Health
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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

52

Study ID:

NCT01609985

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

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