Clinical trial NCT01609985: Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
Official title: Cutaneous Heart Sounds Data Collection During CRT Optimization Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with an implanted Medtronic market approved CRT-D device.

Brief 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.


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

Primary outcomes:
measure: Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors.
timeFrame: A two hour office visit within two years of CRT-Defibrillator (D) and lead system implant
Secondary outcomes:
measure: Comparison of modified Virtuoso® Implantable Cardiac Defibrillator (ICD) heart sounds and CRT-D electrogram (EGM) vectors
timeFrame: A two hour office visit within two years of CRT-D and lead system implant
measure: Determine if modified Virtuoso® ICD recorded heart sounds and CRT-D recorded EGM are able to detect phrenic nerve stimulation (PNS)
timeFrame: A two hour office visit within two years of CRT-D and lead system implant
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Ronald Lo, Inc.
state: California
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Duluth
country: United States
facility: Essentia Institute of Rural Health
state: Minnesota
city: Houston
country: United States
facility: Methodist DeBakey Cardiology Associates
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Medtronic CRDM Clinical
name: Heart Sounds During CRT Clinical Trial Leader
role: STUDY_CHAIR
References: