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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01609985
First received: March 28, 2012
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cutaneous Heart Sounds Data Collection During CRT Optimization Study

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with an implanted Medtronic market approved CRT-D device.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609985

Locations
United States, California
Ronald Lo, Inc.
Riverside, California, United States, 92501
United States, Florida
Orlando Health
Orlando, Florida, United States, 32806
United States, Minnesota
Essentia Institute of Rural Health
Duluth, Minnesota, United States, 55805
United States, Texas
Methodist DeBakey Cardiology Associates
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Heart Sounds During CRT Clinical Trial Leader Medtronic CRDM Clinical
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01609985     History of Changes
Other Study ID Numbers: Heart Sounds During CRT
Study First Received: March 28, 2012
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014