Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
|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: NCT00856349|
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : July 3, 2014
Last Update Posted : July 3, 2014
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Cardiovascular Disease||Behavioral: Therapy Programming Report (TPR)|
|Study Type :||Observational|
|Actual Enrollment :||4384 participants|
|Official Title:||Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Behavioral: Therapy Programming Report (TPR)
Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study.
- Change in Shock Reduction Programming Adoption [ Time Frame: Overall study (20 months on average) ]
Change in percentage of subjects programmed to evidence-based target from baseline (pre-TPR distribution) to last follow-up (post-TPR distribution).
Shock-reduction programming parameters:
LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.
SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.
VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.
VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.
Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.
PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.
- Lead Integrity Alert (LIA) Performance [ Time Frame: Overall study (20 months on average) ]Causes for LIA triggers reported during the study
- Reasons for Inappropriate Shocks [ Time Frame: Overall study (20 months on average) ]Reasons for inappropriate shocks observed during the study
- Actions Taken Following a Shock [ Time Frame: Overall study (20 months on average) ]Characterization of actions taken by the subject immediately following a device shock
- Barriers to Utilization of Shock Reduction Programming [ Time Frame: 24 months follow-up visit ]Characterization of barriers to physician utilization of shock reduction programming
- Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization [ Time Frame: Overall study (20 months on average) ]Characterization of shock reduction programming utilization by subject characteristics and geographical regions
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, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Consent Form (PCF) and authorization for access to and use of health information, if applicable
- Subject has been implanted with a Medtronic market released ICD or CRT-D device (US/Canada - Concerto®/Virtuoso® or newer model; AsiaPacific, Israel, Latin America - EnTrust™, InSync Sentry®, or Concerto®/Virtuoso® or newer model) within the past 30 days
- Subject has commercially released RA (if applicable), RV, and LV (if applicable) leads
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
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): NCT00856349
|Principal Investigator:||Marc Silver, M.D.||Raleigh Cardiology Associates|
|Responsible Party:||Medtronic Cardiac Rhythm and Heart Failure|
|Other Study ID Numbers:||
|First Posted:||March 5, 2009 Key Record Dates|
|Results First Posted:||July 3, 2014|
|Last Update Posted:||July 3, 2014|
|Last Verified:||July 2014|
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Lead Integrity Alert (LIA)
Therapy Programming Report (TPR)