Cardiovascular Disease
Conditions
Keywords
Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy-Defibrillator (CRT-D), Lead Integrity Alert (LIA), Therapy Programming Report (TPR)
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.
Interventions
BEHAVIORALTherapy 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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Shock Reduction Programming Adoption | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lead Integrity Alert (LIA) Performance | Overall study (20 months on average) | Causes for LIA triggers reported during the study |
| Reasons for Inappropriate Shocks | Overall study (20 months on average) | Reasons for inappropriate shocks observed during the study |
| Actions Taken Following a Shock | 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 | 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 | Overall study (20 months on average) | Characterization of shock reduction programming utilization by subject characteristics and geographical regions |
Countries
Argentina, Australia, Canada, China, Hong Kong, India, Mexico, New Zealand, Singapore, South Korea, Taiwan, United States
Participant flow
Recruitment details
Subjects were enrolled in the Shock-Less study between April 2009 and January 2012 from 118 centers worldwide in North America, Central/South America, Australia/New Zealand and Asia.
Pre-assignment details
A total of 252 (6%) out of the 4384 enrolled subjects were excluded from the analysis cohort due to the following reasons: baseline device interrogation not available (217/252; 86%), inclusion/exclusion criteria not met (16/252, 6%), indication for ICD implant not specified (11/252; 4%), and VF therapy/detection not turned ON (8/252; 3%).
Participants by arm
| Arm | Count |
|---|---|
| Analysis Cohort Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
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. | 4,132 |
| Total | 4,132 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 418 |
| Overall Study | Device explant | 33 |
| Overall Study | Lost to Follow-up | 91 |
| Overall Study | Physician Decision | 13 |
| Overall Study | Protocol Violation | 38 |
| Overall Study | Site closure | 78 |
| Overall Study | Subject changed Dr, insurance issue, etc | 130 |
| Overall Study | Subject relocation | 104 |
| Overall Study | Withdrawal by Subject | 116 |
Baseline characteristics
| Characteristic | Analysis Cohort |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 14 Participants |
| Race (NIH/OMB) Asian | 295 Participants |
| Race (NIH/OMB) Black or African American | 360 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 298 Participants |
| Race (NIH/OMB) White | 3151 Participants |
| Region of Enrollment Argentina | 19 participants |
| Region of Enrollment Australia | 69 participants |
| Region of Enrollment Canada | 434 participants |
| Region of Enrollment China | 28 participants |
| Region of Enrollment Hong Kong | 15 participants |
| Region of Enrollment India | 118 participants |
| Region of Enrollment Korea, Republic of | 24 participants |
| Region of Enrollment Mexico | 8 participants |
| Region of Enrollment New Zealand | 26 participants |
| Region of Enrollment Singapore | 39 participants |
| Region of Enrollment Taiwan | 27 participants |
| Region of Enrollment Thailand | 18 participants |
| Region of Enrollment United States | 3307 participants |
| Sex: Female, Male Female | 971 Participants |
| Sex: Female, Male Male | 3161 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Overall study (20 months on average)
Population: Subjects with paired baseline and follow-up programming data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Paired Programming Data | Change in Shock Reduction Programming Adoption | Increase in % on target (LIA) | 13.6 percentage of participants |
| Subjects With Paired Programming Data | Change in Shock Reduction Programming Adoption | Increase in % on target (SVT Limit) | 6.8 percentage of participants |
| Subjects With Paired Programming Data | Change in Shock Reduction Programming Adoption | Increase in % on target (VF NID PP) | 9.0 percentage of participants |
| Subjects With Paired Programming Data | Change in Shock Reduction Programming Adoption | Increase in % on target (VF NID SP) | 3.5 percentage of participants |
| Subjects With Paired Programming Data | Change in Shock Reduction Programming Adoption | Increase in % on target (Wavelet) | 9.5 percentage of participants |
| Subjects With Paired Programming Data | Change in Shock Reduction Programming Adoption | Increase in % on target (PR Logic) | 3.2 percentage of participants |
Comparison: LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.p-value: <0.0001McNemar
Comparison: SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.p-value: <0.0001McNemar
Comparison: VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.p-value: <0.0001McNemar
Comparison: VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.p-value: 0.0116McNemar
Comparison: Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.p-value: <0.0001McNemar
Comparison: PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.p-value: <0.0001McNemar
Secondary
Actions Taken Following a Shock
Characterization of actions taken by the subject immediately following a device shock
Time frame: Overall study (20 months on average)
Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Paired Programming Data | Actions Taken Following a Shock | ER visit | 28 percentage of subjects with shocks |
| Subjects With Paired Programming Data | Actions Taken Following a Shock | Called follow-up clinic | 23 percentage of subjects with shocks |
| Subjects With Paired Programming Data | Actions Taken Following a Shock | Clinic visit | 12.4 percentage of subjects with shocks |
| Subjects With Paired Programming Data | Actions Taken Following a Shock | CareLink transmission | 6.7 percentage of subjects with shocks |
| Subjects With Paired Programming Data | Actions Taken Following a Shock | Off-hours follow-up clinician call | 2.6 percentage of subjects with shocks |
| Subjects With Paired Programming Data | Actions Taken Following a Shock | Urgent Care visit | 0.7 percentage of subjects with shocks |
| Subjects With Paired Programming Data | Actions Taken Following a Shock | Other | 10.2 percentage of subjects with shocks |
| Subjects With Paired Programming Data | Actions Taken Following a Shock | No action taken | 29 percentage of subjects with shocks |
Secondary
Barriers to Utilization of Shock Reduction Programming
Characterization of barriers to physician utilization of shock reduction programming
Time frame: 24 months follow-up visit
Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Paired Programming Data | Barriers to Utilization of Shock Reduction Programming | Physician preference | 51.9 % of subjects not programmed to target |
| Subjects With Paired Programming Data | Barriers to Utilization of Shock Reduction Programming | Medical history | 7.4 % of subjects not programmed to target |
| Subjects With Paired Programming Data | Barriers to Utilization of Shock Reduction Programming | Current subject condition | 3.7 % of subjects not programmed to target |
| Subjects With Paired Programming Data | Barriers to Utilization of Shock Reduction Programming | Utilization of nominal settings | 3.7 % of subjects not programmed to target |
| Subjects With Paired Programming Data | Barriers to Utilization of Shock Reduction Programming | Not reported | 37 % of subjects not programmed to target |
Secondary
Lead Integrity Alert (LIA) Performance
Causes for LIA triggers reported during the study
Time frame: Overall study (20 months on average)
Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | Lead fracture | 30.4 percentage of subjects with LIA triggers |
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | Dislodgment | 8.7 percentage of subjects with LIA triggers |
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | Connector issure | 8.7 percentage of subjects with LIA triggers |
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | RV lead noise | 8.7 percentage of subjects with LIA triggers |
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | VT/VF | 8.7 percentage of subjects with LIA triggers |
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | EMI | 4.3 percentage of subjects with LIA triggers |
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | Oversensing undefined | 17.4 percentage of subjects with LIA triggers |
| Subjects With Paired Programming Data | Lead Integrity Alert (LIA) Performance | Unknown | 17.4 percentage of subjects with LIA triggers |
Secondary
Reasons for Inappropriate Shocks
Reasons for inappropriate shocks observed during the study
Time frame: Overall study (20 months on average)
Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Paired Programming Data | Reasons for Inappropriate Shocks | Other SVT (sinus tach, atrial tach, etc.) | 29.5 percentage of inappropriate shocks |
| Subjects With Paired Programming Data | Reasons for Inappropriate Shocks | AF/AFL | 56.4 percentage of inappropriate shocks |
| Subjects With Paired Programming Data | Reasons for Inappropriate Shocks | T-wave oversensing | 6.9 percentage of inappropriate shocks |
| Subjects With Paired Programming Data | Reasons for Inappropriate Shocks | Oversensing due to lead noise | 6.0 percentage of inappropriate shocks |
| Subjects With Paired Programming Data | Reasons for Inappropriate Shocks | Non-Sustained VT | 0.5 percentage of inappropriate shocks |
| Subjects With Paired Programming Data | Reasons for Inappropriate Shocks | Other | 0.7 percentage of inappropriate shocks |
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
Time frame: Overall study (20 months on average)
Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With Paired Programming Data | Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | VF NID PP % on target - Male | 31.6 percentage of participants |
| Subjects With Paired Programming Data | Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | VF NID PP % on target - Female | 30.2 percentage of participants |
| Subjects With Paired Programming Data | Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | VF NID PP % on target - North America | 31.1 percentage of participants |
| Subjects With Paired Programming Data | Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | VF NID PP % on target - Asia | 31.2 percentage of participants |
| Subjects With Paired Programming Data | Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | VF NID PP % on target - ANZ | 40.3 percentage of participants |
| Subjects With Paired Programming Data | Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization | VF NID PP % on target - Central/South America | 11.1 percentage of participants |