Trial Outcomes & Findings for Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming (NCT NCT00856349)
NCT ID: NCT00856349
Last Updated: 2014-07-03
Results Overview
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.
COMPLETED
4384 participants
Overall study (20 months on average)
2014-07-03
Participant Flow
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.
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%).
Participant milestones
| Measure |
Analysis Cohort
Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
|
|---|---|
|
Overall Study
STARTED
|
4132
|
|
Overall Study
12 Month Follow-up
|
3228
|
|
Overall Study
18 Month Follow-up
|
2467
|
|
Overall Study
24 Month Follow-up
|
1698
|
|
Overall Study
COMPLETED
|
3111
|
|
Overall Study
NOT COMPLETED
|
1021
|
Reasons for withdrawal
| Measure |
Analysis Cohort
Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
|
|---|---|
|
Overall Study
Death
|
418
|
|
Overall Study
Withdrawal by Subject
|
116
|
|
Overall Study
Lost to Follow-up
|
91
|
|
Overall Study
Protocol Violation
|
38
|
|
Overall Study
Physician Decision
|
13
|
|
Overall Study
Subject relocation
|
104
|
|
Overall Study
Device explant
|
33
|
|
Overall Study
Site closure
|
78
|
|
Overall Study
Subject changed Dr, insurance issue, etc
|
130
|
Baseline Characteristics
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Baseline characteristics by cohort
| Measure |
Analysis Cohort
n=4132 Participants
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.
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
971 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3161 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
295 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
360 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3151 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
298 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3307 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
434 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
69 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
26 participants
n=5 Participants
|
|
Region of Enrollment
China
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
24 participants
n=5 Participants
|
|
Region of Enrollment
India
|
118 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Overall study (20 months on average)Population: Subjects with paired baseline and follow-up programming data
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.
Outcome measures
| Measure |
Subjects With Paired Programming Data
n=2201 Participants
Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
|
|---|---|
|
Change in Shock Reduction Programming Adoption
Increase in % on target (LIA)
|
13.6 percentage of participants
|
|
Change in Shock Reduction Programming Adoption
Increase in % on target (SVT Limit)
|
6.8 percentage of participants
|
|
Change in Shock Reduction Programming Adoption
Increase in % on target (VF NID PP)
|
9.0 percentage of participants
|
|
Change in Shock Reduction Programming Adoption
Increase in % on target (VF NID SP)
|
3.5 percentage of participants
|
|
Change in Shock Reduction Programming Adoption
Increase in % on target (Wavelet)
|
9.5 percentage of participants
|
|
Change in Shock Reduction Programming Adoption
Increase in % on target (PR Logic)
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: Overall study (20 months on average)Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Causes for LIA triggers reported during the study
Outcome measures
| Measure |
Subjects With Paired Programming Data
n=23 Subjects who experienced LIA triggers
Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
|
|---|---|
|
Lead Integrity Alert (LIA) Performance
Lead fracture
|
30.4 percentage of subjects with LIA triggers
|
|
Lead Integrity Alert (LIA) Performance
Dislodgment
|
8.7 percentage of subjects with LIA triggers
|
|
Lead Integrity Alert (LIA) Performance
Connector issure
|
8.7 percentage of subjects with LIA triggers
|
|
Lead Integrity Alert (LIA) Performance
RV lead noise
|
8.7 percentage of subjects with LIA triggers
|
|
Lead Integrity Alert (LIA) Performance
VT/VF
|
8.7 percentage of subjects with LIA triggers
|
|
Lead Integrity Alert (LIA) Performance
EMI
|
4.3 percentage of subjects with LIA triggers
|
|
Lead Integrity Alert (LIA) Performance
Oversensing undefined
|
17.4 percentage of subjects with LIA triggers
|
|
Lead Integrity Alert (LIA) Performance
Unknown
|
17.4 percentage of subjects with LIA triggers
|
SECONDARY outcome
Timeframe: Overall study (20 months on average)Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Reasons for inappropriate shocks observed during the study
Outcome measures
| Measure |
Subjects With Paired Programming Data
n=553 inappropriate shocks
Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
|
|---|---|
|
Reasons for Inappropriate Shocks
AF/AFL
|
56.4 percentage of inappropriate shocks
|
|
Reasons for Inappropriate Shocks
Other SVT (sinus tach, atrial tach, etc.)
|
29.5 percentage of inappropriate shocks
|
|
Reasons for Inappropriate Shocks
T-wave oversensing
|
6.9 percentage of inappropriate shocks
|
|
Reasons for Inappropriate Shocks
Oversensing due to lead noise
|
6.0 percentage of inappropriate shocks
|
|
Reasons for Inappropriate Shocks
Non-Sustained VT
|
0.5 percentage of inappropriate shocks
|
|
Reasons for Inappropriate Shocks
Other
|
0.7 percentage of inappropriate shocks
|
SECONDARY outcome
Timeframe: Overall study (20 months on average)Population: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Characterization of actions taken by the subject immediately following a device shock
Outcome measures
| Measure |
Subjects With Paired Programming Data
n=421 Subjects who experienced shocks
Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
|
|---|---|
|
Actions Taken Following a Shock
ER visit
|
28 percentage of subjects with shocks
|
|
Actions Taken Following a Shock
Called follow-up clinic
|
23 percentage of subjects with shocks
|
|
Actions Taken Following a Shock
Clinic visit
|
12.4 percentage of subjects with shocks
|
|
Actions Taken Following a Shock
CareLink transmission
|
6.7 percentage of subjects with shocks
|
|
Actions Taken Following a Shock
Off-hours follow-up clinician call
|
2.6 percentage of subjects with shocks
|
|
Actions Taken Following a Shock
Urgent Care visit
|
0.7 percentage of subjects with shocks
|
|
Actions Taken Following a Shock
Other
|
10.2 percentage of subjects with shocks
|
|
Actions Taken Following a Shock
No action taken
|
29 percentage of subjects with shocks
|
SECONDARY outcome
Timeframe: 24 months follow-up visitPopulation: Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Characterization of barriers to physician utilization of shock reduction programming
Outcome measures
| Measure |
Subjects With Paired Programming Data
n=27 Subjects not programmed to target
Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
|
|---|---|
|
Barriers to Utilization of Shock Reduction Programming
Physician preference
|
51.9 % of subjects not programmed to target
|
|
Barriers to Utilization of Shock Reduction Programming
Medical history
|
7.4 % of subjects not programmed to target
|
|
Barriers to Utilization of Shock Reduction Programming
Current subject condition
|
3.7 % of subjects not programmed to target
|
|
Barriers to Utilization of Shock Reduction Programming
Utilization of nominal settings
|
3.7 % of subjects not programmed to target
|
|
Barriers to Utilization of Shock Reduction Programming
Not reported
|
37 % of subjects not programmed to target
|
SECONDARY outcome
Timeframe: 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.
Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Outcome measures
| Measure |
Subjects With Paired Programming Data
n=3714 Participants
Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
|
|---|---|
|
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
VF NID PP % on target - Male
|
31.6 percentage of participants
|
|
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
VF NID PP % on target - Female
|
30.2 percentage of participants
|
|
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
VF NID PP % on target - North America
|
31.1 percentage of participants
|
|
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
VF NID PP % on target - Asia
|
31.2 percentage of participants
|
|
Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
VF NID PP % on target - ANZ
|
40.3 percentage of participants
|
|
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
|
Adverse Events
Analysis Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Daniel Lexcen, Clinical Research Specialist
Medtronic Cardiac Rhythm Disease Management
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
- Publication restrictions are in place
Restriction type: OTHER