N/A
N=4,132
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00856349 ↗Enrolled (actual)
4,132
Serious AEs
—
Results posted
Jul 2014
Primary outcome: Primary: Change in Shock Reduction Programming Adoption — 13.6; 6.8; 9.0; 3.5 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Therapy Programming Report (TPR) (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Shock Reduction Programming Adoption |
13.6; 6.8; 9.0; 3.5; 9.5; 3.2 | <0.0001 sig |
| SECONDARY Lead Integrity Alert (LIA) Performance |
30.4; 8.7; 8.7; 8.7; 8.7; 4.3 | — |
| SECONDARY Reasons for Inappropriate Shocks |
56.4; 29.5; 6.9; 6.0; 0.5; 0.7 | — |
| SECONDARY Actions Taken Following a Shock |
28; 23; 12.4; 6.7; 2.6; 0.7 | — |
| SECONDARY Barriers to Utilization of Shock Reduction Programming |
51.9; 7.4; 3.7; 3.7; 37 | — |
| SECONDARY Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization |
31.6; 30.2; 31.1; 31.2; 40.3; 11.1 | — |
Summary
The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for defibrillators.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
Data sourced from ClinicalTrials.gov (NCT00856349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.