Trial record 2 of 13 for:
Medtronic Vectors
Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
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| ClinicalTrials.gov Identifier: NCT01609985 |
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Recruitment Status :
Completed
First Posted : June 1, 2012
Last Update Posted : July 1, 2013
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Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
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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.
| Condition or disease |
|---|
| Heart Failure |
| Study Type : | Observational |
| Actual Enrollment : | 52 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Cutaneous Heart Sounds Data Collection During CRT Optimization Study |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
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 ]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 ]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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 and Heart Failure
Investigators
| Study Chair: | Heart Sounds During CRT Clinical Trial Leader | Medtronic CRDM Clinical |
| Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
| ClinicalTrials.gov Identifier: | NCT01609985 |
| Other Study ID Numbers: |
Heart Sounds During CRT |
| First Posted: | June 1, 2012 Key Record Dates |
| Last Update Posted: | July 1, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
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Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |