Medtronic Shock-Less Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Cardiac Rhythm Disease Management

ClinicalTrials.gov Identifier:

NCT00856349

First received: February 26, 2009

Last updated: November 1, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 26, 2009

Last Updated Date

November 1, 2012

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects with changes in shock reduction programming from baseline to the end of follow-up. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Determine whether periodic reports provided to study centers can increase the utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00856349 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Lead Integrity Alert performance data. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Reasons for inappropriate shocks. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Barriers to utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Actions taken following a shock. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Utilization of shock reduction programming. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Medtronic Shock-Less Study

Official Title ^ICMJE

Medtronic Shock-Less Study

Brief 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.

Detailed 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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Subjects implanted with a Medtronic market released single, dual, or triple chamber defibrillator (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 are eligible for participation in the study.

Condition ^ICMJE

Cardiovascular Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

4380

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00856349

Other Study ID Numbers ^ICMJE

Shock-Less

Has Data Monitoring Committee

Responsible Party

Medtronic Cardiac Rhythm Disease Management

Study Sponsor ^ICMJE

Medtronic Cardiac Rhythm Disease Management

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marc Silver, M.D.

Raleigh Cardiology Associates

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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