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

• ClinicalTrials.gov Identifier: NCT01609985
• Recruitment Status: Completed
• First Posted: June 1, 2012
• Last Update Posted: July 1, 2013
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• 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

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

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

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