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

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01609985

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

52

Starts

2012-03-01

Expected to finish

2012-12-01

Last updated by the study team

2013-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ronald Lo, Inc. — Riverside, California, United States
• Orlando Health — Orlando, Florida, United States
• Essentia Institute of Rural Health — Duluth, Minnesota, United States
• Methodist DeBakey Cardiology Associates — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.