Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming

Cardiovascular Disease Clinical Trial

Official title:

Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856349
• Other study ID #: Shock-Less
• Status: Completed
• Phase: N/A
• First received: February 26, 2009
• Last updated: July 1, 2014
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2014
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeAustralia: Human Research Ethics CommitteeBrazil: Ethics CommitteeChina: Medical Ethics CommitteeColombia: Institutional Review BoardHong Kong: Research Ethics CommitteeIndia: Ethics CommitteeIsrael: Ethics CommitteeMexico: Ethics CommitteeNew Zealand: Regional Ethics CommitteeSingapore: Domain Specific Review BoardsSouth Korea: Institutional Review BoardTaiwan: Institutional Review BoardThailand: Research Ethics CommitteeVenezuela: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

Shocks delivered to patients by defibrillators, while life-saving, can create anxiety, pain and decrease quality of life. Previous studies have shown that device programming and features can safely reduce the number of shocks patients receive. This study will explore the extent to which physicians use these programming and features. It will determine whether repeat and frequent awareness to how they program their own subjects and the programming trends of all enrolled subjects will change their programming patterns. This will be accomplished by understanding physicians' device programming behaviors and providing reports as a tool to help physicians manage their subjects and provide shock reduction programming recommended by previous publications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4384
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  China,  Hong Kong,  India,  Korea, Republic of,  Mexico,  New Zealand,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Shock Reduction Programming Adoption	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.	Overall study (20 months on average)	No
Secondary	Lead Integrity Alert (LIA) Performance	Causes for LIA triggers reported during the study	Overall study (20 months on average)	No
Secondary	Reasons for Inappropriate Shocks	Reasons for inappropriate shocks observed during the study	Overall study (20 months on average)	No
Secondary	Actions Taken Following a Shock	Characterization of actions taken by the subject immediately following a device shock	Overall study (20 months on average)	No
Secondary	Barriers to Utilization of Shock Reduction Programming	Characterization of barriers to physician utilization of shock reduction programming	24 months follow-up visit	No
Secondary	Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization	Characterization of shock reduction programming utilization by subject characteristics and geographical regions	Overall study (20 months on average)	No