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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01609985
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : July 1, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date March 28, 2012
First Posted Date June 1, 2012
Last Update Posted Date July 1, 2013
Study Start Date March 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2012)
Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors. [ Time Frame: A two hour office visit within two years of CRT-Defibrillator (D) and lead system implant ]
The cardiac signals collected by the modified Virtuoso® ICD and implanted CRT-D EGM vectors will be used to determine how to improve and finalize a prototyped hemodynamic sensor-based CRT optimization scheme.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 30, 2012)
  • Comparison of modified Virtuoso® Implantable Cardiac Defibrillator (ICD) heart sounds and CRT-D electrogram (EGM) vectors [ Time Frame: A two hour office visit within two years of CRT-D and lead system implant ]
    The heart sounds vector data from the externally affixed modified Virtuoso® ICD will be compared to the EGM vectors from the implanted CRT-D device after CRT optimization.
  • Determine if modified Virtuoso® ICD recorded heart sounds and CRT-D recorded EGM are able to detect phrenic nerve stimulation (PNS) [ Time Frame: A two hour office visit within two years of CRT-D and lead system implant ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
Official Title Cutaneous Heart Sounds Data Collection During CRT Optimization Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with an implanted Medtronic market approved CRT-D device.
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2013)
52
Original Estimated Enrollment
 (submitted: May 30, 2012)
50
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01609985
Other Study ID Numbers Heart Sounds During CRT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Original Responsible Party Same as current
Current Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Heart Sounds During CRT Clinical Trial Leader Medtronic CRDM Clinical
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date June 2013