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

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00856349
• Collaborator: (none)
• Enrollment: 4,384
• Locations: 104
• Duration (Months): 47
• Patients Per Site: 42.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Behavioral: Therapy Programming Report (TPR)

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

• Study Type: Observational
• Actual Enrollment: 4384 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Analysis cohort Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.	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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Lead Integrity Alert (LIA) Performance [Overall study (20 months on average)]

   Causes for LIA triggers reported during the study

2. Reasons for Inappropriate Shocks [Overall study (20 months on average)]

   Reasons for inappropriate shocks observed during the study

3. Actions Taken Following a Shock [Overall study (20 months on average)]

   Characterization of actions taken by the subject immediately following a device shock

4. Barriers to Utilization of Shock Reduction Programming [24 months follow-up visit]

   Characterization of barriers to physician utilization of shock reduction programming

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anniston	Alabama	United States
2		Phoenix	Arizona	United States
3		Tucson	Arizona	United States
4		Hot Springs	Arkansas	United States
5		Little Rock	Arkansas	United States
6		Fremont	California	United States
7		Fresno	California	United States
8		Modesto	California	United States
9		Northridge	California	United States
10		Orange	California	United States
11		San Bernardino/Los Angeles	California	United States
12		Ventura	California	United States
13		New Haven	Connecticut	United States
14		Fort Lauderdale	Florida	United States
15		Jacksonville	Florida	United States
16		Ocala	Florida	United States
17		Palm Beach Gardens	Florida	United States
18		Pensacola	Florida	United States
19		Plantation	Florida	United States
20		Rockledge	Florida	United States
21		St. Petersburg	Florida	United States
22		Zephyrhills	Florida	United States
23		Atlanta	Georgia	United States
24		Berwyn	Illinois	United States
25		Elk Grove Village	Illinois	United States
26		Maywood	Illinois	United States
27		Evansville	Indiana	United States
28		Fort Wayne	Indiana	United States
29		Scarborough	Maine	United States
30		Baltimore	Maryland	United States
31		Takoma Park	Maryland	United States
32		New Bedford	Massachusetts	United States
33		Flint	Michigan	United States
34		Kalamazoo	Michigan	United States
35		Lansing	Michigan	United States
36		St. Joseph	Michigan	United States
37		Robbinsdale	Minnesota	United States
38		St. Louis Park	Minnesota	United States
39		Jackson	Mississippi	United States
40		St. Louis	Missouri	United States
41		Lincoln	Nebraska	United States
42		Las Vegas	Nevada	United States
43		Cherry Hill	New Jersey	United States
44		Clifton	New Jersey	United States
45		Flemington	New Jersey	United States
46		Newark	New Jersey	United States
47		Albuquerque	New Mexico	United States
48		Elmira	New York	United States
49		Flushing	New York	United States
50		New York	New York	United States
51		Utica	New York	United States
52		Williamsville	New York	United States
53		Charlotte	North Carolina	United States
54		Raleigh	North Carolina	United States
55		Wilmington	North Carolina	United States
56		Winston Salem	North Carolina	United States
57		Fargo	North Dakota	United States
58		Cincinnati	Ohio	United States
59		Cleveland	Ohio	United States
60		Columbus	Ohio	United States
61		Mansfield	Ohio	United States
62		Youngstown	Ohio	United States
63		Lawton	Oklahoma	United States
64		Tulsa	Oklahoma	United States
65		Medford	Oregon	United States
66		Erie	Pennsylvania	United States
67		Philadelphia	Pennsylvania	United States
68		Wyomissing	Pennsylvania	United States
69		Charleston	South Carolina	United States
70		Columbia	South Carolina	United States
71		Sioux Falls	South Dakota	United States
72		Chattanooga	Tennessee	United States
73		Nashville	Tennessee	United States
74		El Paso	Texas	United States
75		Fort Sam Houston	Texas	United States
76		Houston	Texas	United States
77		Mc Allen	Texas	United States
78		Tyler	Texas	United States
79		Charlottesville	Virginia	United States
80		Manassas	Virginia	United States
81		Charleston	West Virginia	United States
82		Morgantown	West Virginia	United States
83		Milwaukee	Wisconsin	United States
84		Buenos Aires		Argentina
85		Adelaide	South Australia	Australia
86		Frankston	Victoria	Australia
87		Perth	Western Australia	Australia
88		Edmonton	Alberta	Canada
89		Victoria	British Columbia	Canada
90		Winnipeg	Manitoba	Canada
91		Kitchener	Ontario	Canada
92		Toronto	Ontario	Canada
93		Montréal	Quebec	Canada
94		Sherbrooke	Quebec	Canada
95		Guangzhou	Guangdong	China
96		Beijing		China
97		Kowloon		Hong Kong
98		New Dehli	Delhi	India
99		Saket	New Dehli	India
100		Seoul		Korea, Republic of
101		Mexico City		Mexico
102		Frankton	Hamilton	New Zealand
103		Singapore		Singapore
104		Kaohsiung		Taiwan

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Marc Silver, M.D., Raleigh Cardiology Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT00856349
• Other Study ID Numbers: Shock-Less
• First Posted: Mar 5, 2009
• Last Update Posted: Jul 3, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Medtronic Cardiac Rhythm and Heart Failure: Implantable Cardioverter Defibrillator (ICD); Cardiac Resynchronization Therapy-Defibrillator (CRT-D); Lead Integrity Alert (LIA); Therapy Programming Report (TPR)
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

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 Detail	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%).

Arm/Group Title	Analysis Cohort
Arm/Group Description	Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
Period Title: Overall Study
STARTED	4132
12 Month Follow-up	3228
18 Month Follow-up	2467
24 Month Follow-up	1698
COMPLETED	3111
NOT COMPLETED	1021

Baseline Characteristics

Arm/Group Title	Analysis Cohort
Arm/Group Description	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.
Overall Participants	4132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (13)
Sex: Female, Male (Count of Participants)
Female	971 23.5%
Male	3161 76.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	14 0.3%
Asian	295 7.1%
Native Hawaiian or Other Pacific Islander	9 0.2%
Black or African American	360 8.7%
White	3151 76.3%
More than one race	5 0.1%
Unknown or Not Reported	298 7.2%
Region of Enrollment (participants) [Number]
United States	3307 80%
Taiwan	27 0.7%
Hong Kong	15 0.4%
Mexico	8 0.2%
Canada	434 10.5%
Argentina	19 0.5%
Singapore	39 0.9%
Australia	69 1.7%
New Zealand	26 0.6%
China	28 0.7%
Korea, Republic of	24 0.6%
India	118 2.9%
Thailand	18 0.4%

Outcome Measures

1. Primary Outcome

Title	Change in Shock Reduction Programming Adoption
Description	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)

Outcome Measure Data

Analysis Population Description

Subjects with paired baseline and follow-up programming data

Arm/Group Title	Subjects With Paired Programming Data
Arm/Group Description	Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
Measure Participants	2201
Increase in % on target (LIA)	13.6 0.3%
Increase in % on target (SVT Limit)	6.8 0.2%
Increase in % on target (VF NID PP)	9.0 0.2%
Increase in % on target (VF NID SP)	3.5 0.1%
Increase in % on target (Wavelet)	9.5 0.2%
Increase in % on target (PR Logic)	3.2 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Subjects With Paired Programming Data
	Comments	LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Increase in % on target (LIA)
	Estimated Value	13.6
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Subjects With Paired Programming Data
	Comments	SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Increase in % on target (SVT Limit)
	Estimated Value	6.8
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Subjects With Paired Programming Data
	Comments	VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Increase in % on target (VF NID PP)
	Estimated Value	9.0
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Subjects With Paired Programming Data
	Comments	VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0116
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Increase in % on target (VF NID SP)
	Estimated Value	3.5
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Subjects With Paired Programming Data
	Comments	Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Increase in % on target (Wavelet)
	Estimated Value	9.5
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Subjects With Paired Programming Data
	Comments	PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Increase in % on target (PR Logic)
	Estimated Value	3.2
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Lead Integrity Alert (LIA) Performance
Description	Causes for LIA triggers reported during the study
Time Frame	Overall study (20 months on average)

Outcome Measure Data

Analysis Population Description

Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

Arm/Group Title	Analysis Cohort
Arm/Group Description	Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Measure Participants	4132
Measure Subjects who experienced LIA triggers	23
Lead fracture	30.4
Dislodgment	8.7
Connector issure	8.7
RV lead noise	8.7
VT/VF	8.7
EMI	4.3
Oversensing undefined	17.4
Unknown	17.4

3. Secondary Outcome

Title	Reasons for Inappropriate Shocks
Description	Reasons for inappropriate shocks observed during the study
Time Frame	Overall study (20 months on average)

Outcome Measure Data

Analysis Population Description

Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

Arm/Group Title	Analysis Cohort
Arm/Group Description	Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Measure Participants	4132
Measure inappropriate shocks	553
AF/AFL	56.4
Other SVT (sinus tach, atrial tach, etc.)	29.5
T-wave oversensing	6.9
Oversensing due to lead noise	6.0
Non-Sustained VT	0.5
Other	0.7

4. Secondary Outcome

Title	Actions Taken Following a Shock
Description	Characterization of actions taken by the subject immediately following a device shock
Time Frame	Overall study (20 months on average)

Outcome Measure Data

Analysis Population Description

Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

Arm/Group Title	Analysis Cohort
Arm/Group Description	Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Measure Participants	4132
Measure Subjects who experienced shocks	421
ER visit	28
Called follow-up clinic	23
Clinic visit	12.4
CareLink transmission	6.7
Off-hours follow-up clinician call	2.6
Urgent Care visit	0.7
Other	10.2
No action taken	29

5. Secondary Outcome

Title	Barriers to Utilization of Shock Reduction Programming
Description	Characterization of barriers to physician utilization of shock reduction programming
Time Frame	24 months follow-up visit

Outcome Measure Data

Analysis Population Description

Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.

Arm/Group Title	Analysis Cohort
Arm/Group Description	Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
Measure Participants	1698
Measure Subjects not programmed to target	27
Physician preference	51.9
Medical history	7.4
Current subject condition	3.7
Utilization of nominal settings	3.7
Not reported	37

6. Secondary Outcome

Title	Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
Description	Characterization of shock reduction programming utilization by subject characteristics and geographical regions
Time Frame	Overall study (20 months on average)

Outcome Measure Data

Analysis Population Description

Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.

Arm/Group Title	Subjects With Final Programming Data Available
Arm/Group Description	Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.
Measure Participants	3714
VF NID PP % on target - Male	31.6 0.8%
VF NID PP % on target - Female	30.2 0.7%
VF NID PP % on target - North America	31.1 0.8%
VF NID PP % on target - Asia	31.2 0.8%
VF NID PP % on target - ANZ	40.3 1%
VF NID PP % on target - Central/South America	11.1 0.3%

Adverse Events

Adverse Event Reporting Description	Adverse events were not collected in this study
Arm/Group Title	Analysis Cohort
Arm/Group Description	Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
All Cause Mortality
	Analysis Cohort
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Analysis Cohort
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Analysis Cohort
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.