Cardiovascular DiseaseNCT00856349
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
An observational study of Cardiovascular Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 104 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Therapy Programming Report (TPR)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,384 participants
- Where
- 104 sitesin 12 countries
- Study dates
- Apr 2009to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
Trial locations and contacts
104 sites in 12 countries.
104 sites in 12 countries
United States83 sites
Study site
Albuquerque, New Mexico
Study site
Anniston, Alabama
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Berwyn, Illinois
Study site
Charleston, South Carolina
Study site
Charleston, West Virginia
Study site
Charlotte, North Carolina
Study site
Charlottesville, Virginia
Study site
Chattanooga, Tennessee
Study site
Cherry Hill, New Jersey
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Clifton, New Jersey
Study site
Columbia, South Carolina
Study site
Columbus, Ohio
Study site
El Paso, Texas
Study site
Elk Grove Village, Illinois
Study site
Elmira, New York
Study site
Erie, Pennsylvania
Study site
Evansville, Indiana
Study site
Fargo, North Dakota
Study site
Flemington, New Jersey
Study site
Flint, Michigan
Study site
Flushing, New York
Study site
Fort Lauderdale, Florida
Study site
Fort Sam Houston, Texas
Study site
Fort Wayne, Indiana
Study site
Fremont, California
Study site
Fresno, California
Study site
Hot Springs, Arkansas
Study site
Houston, Texas
Study site
Jackson, Mississippi
Study site
Jacksonville, Florida
Study site
Kalamazoo, Michigan
Study site
Lansing, Michigan
Study site
Las Vegas, Nevada
Study site
Lawton, Oklahoma
Study site
Lincoln, Nebraska
Study site
Little Rock, Arkansas
Study site
Manassas, Virginia
Study site
Mansfield, Ohio
Study site
Maywood, Illinois
Study site
McAllen, Texas
Study site
Medford, Oregon
Study site
Milwaukee, Wisconsin
Study site
Modesto, California
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
New Bedford, Massachusetts
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Newark, New Jersey
Study site
Northridge, California
Study site
Ocala, Florida
Study site
Orange, California
Study site
Palm Beach Gardens, Florida
Study site
Pensacola, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Plantation, Florida
Study site
Raleigh, North Carolina
Study site
Robbinsdale, Minnesota
Study site
Rockledge, Florida
Study site
Saint Joseph, Michigan
Study site
Saint Louis Park, Minnesota
Study site
San Bernardino/Los Angeles, California
Study site
Scarborough, Maine
Study site
Sioux Falls, South Dakota
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Takoma Park, Maryland
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Tyler, Texas
Study site
Utica, New York
Study site
Ventura, California
Study site
Williamsville, New York
Study site
Wilmington, North Carolina
Study site
Winston-Salem, North Carolina
Study site
Wyomissing, Pennsylvania
Study site
Youngstown, Ohio
Study site
Zephyrhills, Florida
Canada7 sites
Study site
Edmonton, Alberta
Study site
Kitchener, Ontario
Study site
Montreal, Quebec
Study site
Sherbrooke, Quebec
Study site
Toronto, Ontario
Study site
Victoria, British Columbia
Study site
Winnipeg, Manitoba
Australia3 sites
Study site
Adelaide, South Australia
Study site
Frankston, Victoria
Study site
Perth, Western Australia
India2 sites
Study site
New Dehli, National Capital Territory of Delhi
Study site
Sāket, New Dehli
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Therapy Programming Report (TPR)
- Keywords
- Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy-Defibrillator (CRT-D), Lead Integrity Alert (LIA), Therapy Programming Report (TPR)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy Programming Report (TPR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Analysis cohort | Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. Receives: Behavioral: Therapy Programming Report (TPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Overall study (20 months on average)
Secondary outcomes (5)
Lead Integrity Alert (LIA) Performance
Causes for LIA triggers reported during the study
Measured: Overall study (20 months on average)
Reasons for Inappropriate Shocks
Reasons for inappropriate shocks observed during the study
Measured: Overall study (20 months on average)
Actions Taken Following a Shock
Characterization of actions taken by the subject immediately following a device shock
Measured: Overall study (20 months on average)
Barriers to Utilization of Shock Reduction Programming
Characterization of barriers to physician utilization of shock reduction programming
Measured: 24 months follow-up visit
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Measured: Overall study (20 months on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Silver, M.D., Principal investigator, Raleigh Cardiology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856349
- Sponsor's protocol ID
- Shock-Less
- Status last verified
- Jul 2014
- First submitted
- 26 Feb 2009
- Last updated
- 3 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Joung B, Lexcen DR, Ching CK, Silver MT, Piccini JP, Sterns LD, Rabinovich R, Pickett RA, Liu S, Brown ML, Cheng A. Additional antitachycardia pacing programming strategies further reduce unnecessary implantable cardioverter-defibrillator shocks. Heart Rhythm. 2020 Jan;17(1):98-105. doi: 10.1016/j.hrthm.2019.07.027. Epub 2019 Jul 29.
PubMed 31369873
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
- ClinicalTrials.gov ID
- NCT00856349
- Acronym / sponsor ID
- Shock-Less
- Conditions
- Cardiovascular Disease
- Keywords
- Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy-Defibrillator (CRT-D), Lead Integrity Alert (LIA), Therapy Programming Report (TPR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,384 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Posted 3 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Analysis cohort | – | Behavioral: Therapy Programming Report (TPR)Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Analysis cohort |
Primary outcome
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.
5 secondary outcomes
Lead Integrity Alert (LIA) Performance
Time frame: Overall study (20 months on average)
Reasons for Inappropriate Shocks
Time frame: Overall study (20 months on average)
Actions Taken Following a Shock
Time frame: Overall study (20 months on average)
Barriers to Utilization of Shock Reduction Programming
Time frame: 24 months follow-up visit
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
Time frame: Overall study (20 months on average)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31369873Joung B, Lexcen DR, Ching CK, Silver MT, Piccini JP, Sterns LD, Rabinovich R, Pickett RA, Liu S, Brown ML, Cheng A. Additional antitachycardia pacing programming strategies further reduce unnecessary implantable cardioverter-defibrillator shocks. Heart Rhythm. 2020 Jan;17(1):98-105. doi: 10.1016/j.hrthm.2019.07.027. Epub 2019 Jul 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Silver, M.D. principal investigator
Raleigh Cardiology Associates
104 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 104 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Canada, Australia, China, India and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Shock Reduction Programming Adoption (time frame: Overall study (20 months on average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00856349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.