Model 4965 Post-Approval Study

• Sponsor: Medtronic (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01076348
• Collaborator: (none)
• Enrollment: 73
• Locations: 107
• Duration (Months): 174.9
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Pacing; Bradycardia; Arrhythmia

Detailed Description

As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.

Study Design

• Study Type: Observational
• Actual Enrollment: 73 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study
• Study Start Date: Sep 1, 1996
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Outcome Measures

Primary Outcome Measures

1. Model 4965 Complication Free Rate [1 year]

   A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB

AND one of the following (A, B, or C) must also apply:

1. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.

2. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:

• product is market-released

• complete implant and follow-up data, including product-related adverse events, are available

• subject or appropriate legal guardian authorizes release of subject study data to SLS

1. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.

Exclusion Criteria:

• Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant

• Subjects who are, or will be inaccessible for follow-up at a SLS center

• Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded

• Subjects with exclusion criteria required by local law (EMEA only)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Anchorage	Alaska	United States
3		Phoenix	Arizona	United States
4		Scottsdale	Arizona	United States
5		Little Rock	Arkansas	United States
6		Bakersfield	California	United States
7		Chula Vista	California	United States
8		Downey	California	United States
9		East Palo Alto	California	United States
10		Los Angeles	California	United States
11		Salinas	California	United States
12		Torrance	California	United States
13		Van Nuys	California	United States
14		Colorado Springs	Colorado	United States
15		Denver	Colorado	United States
16		Washington	District of Columbia	United States
17		Clearwater	Florida	United States
18		Jacksonville	Florida	United States
19		Melbourne	Florida	United States
20		Ocala	Florida	United States
21		Wellington	Florida	United States
22		Atlanta	Georgia	United States
23		Columbus	Georgia	United States
24		Marietta	Georgia	United States
25		Oak Lawn	Illinois	United States
26		Indianapolis	Indiana	United States
27		Newburgh	Indiana	United States
28		Des Moines	Iowa	United States
29		Kansas City	Kansas	United States
30		Lexington	Kentucky	United States
31		Louisville	Kentucky	United States
32		Alexandria	Louisiana	United States
33		Baton Rouge	Louisiana	United States
34		Salisbury	Maryland	United States
35		Silver Spring	Maryland	United States
36		Towson	Maryland	United States
37		Grand Blanc	Michigan	United States
38		Marquette	Michigan	United States
39		Saginaw	Michigan	United States
40		Southfield	Michigan	United States
41		Robbinsdale	Minnesota	United States
42		Rochester	Minnesota	United States
43		Saint Paul	Minnesota	United States
44		Kansas City	Missouri	United States
45		Lebanon	New Hampshire	United States
46		Browns Mills	New Jersey	United States
47		Newark	New Jersey	United States
48		Ocean City	New Jersey	United States
49		Parlin	New Jersey	United States
50		West Orange	New Jersey	United States
51		Albuquerque	New Mexico	United States
52		Mineola	New York	United States
53		Rochester	New York	United States
54		Greensboro	North Carolina	United States
55		Hickory	North Carolina	United States
56		Cincinnati	Ohio	United States
57		Cleveland	Ohio	United States
58		Columbus	Ohio	United States
59		Toledo	Ohio	United States
60		Portland	Oregon	United States
61		Doylestown	Pennsylvania	United States
62		Lancaster	Pennsylvania	United States
63		Sayre	Pennsylvania	United States
64		Columbia	South Carolina	United States
65		Florence	South Carolina	United States
66		Sioux Falls	South Dakota	United States
67		Chattanooga	Tennessee	United States
68		Germantown	Tennessee	United States
69		Memphis	Tennessee	United States
70		Nashville	Tennessee	United States
71		Amarillo	Texas	United States
72		Austin	Texas	United States
73		Dallas	Texas	United States
74		Fort Worth	Texas	United States
75		Houston	Texas	United States
76		San Antonio	Texas	United States
77		The Woodlands	Texas	United States
78		Burlington	Vermont	United States
79		Chesapeake	Virginia	United States
80		Fairfax	Virginia	United States
81		Olympia	Washington	United States
82		Spokane	Washington	United States
83		Madison	Wisconsin	United States
84		Milwaukee	Wisconsin	United States
85		Bedford Park	South Australia	Australia
86		Linz		Austria
87		Vienna		Austria
88		Hasselt		Belgium
89		Calgary	Alberta	Canada
90		Hamilton	Ontario	Canada
91		Ottawa	Ontario	Canada
92		Toronto	Ontario	Canada
93		Montreal	Quebec	Canada
94		Ste-Foy	Quebec	Canada
95		Regina	Saskatchewan	Canada
96		Copenhagen		Denmark
97		Marseille		France
98		Homburg/Saar		Germany
99		Catanzaro		Italy
100		Reggio Emilia		Italy
101		Udine		Italy
102		Eindhoven		Netherlands
103		Rotterdam		Netherlands
104		Belgrad		Serbia
105		Valencia		Spain
106		Skovde		Sweden
107		Zurich		Switzerland

Sponsors and Collaborators

• Medtronic

Investigators

• Study Chair: 4965 Post-Approval Study Clinical Trial Leader, Medtronic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic
• ClinicalTrials.gov Identifier: NCT01076348
• Other Study ID Numbers: 4965
• First Posted: Feb 26, 2010
• Last Update Posted: Feb 27, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Medtronic: Epicardial; Pacing Lead
• Additional relevant MeSH terms: Bradycardia

Study Results

Participant Flow

Recruitment Details	The study utilized centers that had implanted model 4965 leads in adult subjects to obtain information regarding safety, lead events, and lead survival.

Arm/Group Title	Medtronic 4965 Subjects
Arm/Group Description	Single arm registry of Model 4965 implanted patients
Period Title: Overall Study
STARTED	73
COMPLETED	51
NOT COMPLETED	22

Baseline Characteristics

Arm/Group Title	Medtronic 4965 Subjects
Arm/Group Description	Single arm registry of Model 4965 implanted patients
Overall Participants	73
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	32 43.8%
>=65 years	41 56.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.8 (15.5)
Sex: Female, Male (Count of Participants)
Female	29 39.7%
Male	44 60.3%
Region of Enrollment (participants) [Number]
United States	72 98.6%
Germany	1 1.4%

Outcome Measures

1. Primary Outcome

Title	Model 4965 Complication Free Rate
Description	A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead.

Arm/Group Title	Medtronic 4965 Epicardial Lead
Arm/Group Description	Subjects who were implanted with at least 1 model 4965 lead.
Measure Participants	73
Measure 4965 leads	98
Number (95% Confidence Interval) [Model 4965 complication free rate]	98.8

Adverse Events

Adverse Event Reporting Description	For this study, "serious" is defined as requiring an invasive intervention to resolve.
Arm/Group Title	Medtronic 4965 Subjects
Arm/Group Description	Single arm registry of Model 4965 implanted patients
All Cause Mortality
	Medtronic 4965 Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Medtronic 4965 Subjects
	Affected / at Risk (%)	# Events
Total	2/73 (2.7%)
Vascular disorders
Failure to capture	1/73 (1.4%)	1
Lead conductor fracture	1/73 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Medtronic 4965 Subjects
	Affected / at Risk (%)	# Events
Total	0/73 (0%)

Limitations/Caveats

The study cohort was limited to subjects >19 years of age at the time of implant, limiting the survival analysis of the Model 4965 lead in a pediatric population.

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.