DF4 Connector System Post-Approval Study

Sponsor

Medtronic (Industry)

Overall Status

Completed

CT.gov ID

NCT01638897

Collaborator

(none)

1,778

Enrollment

Locations

85.9

Duration (Months)

22.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia Ventricular Fibrillation Sudden Cardiac Death Heart Failure

Study Design

Study Type:

Observational

Actual Enrollment :

1778 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

DF4 Connector System Post-Approval Study

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Outcome Measures

Primary Outcome Measures

DF4 Lead Related Complication Rate [Up to 5 Years]
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead

Secondary Outcome Measures

Types of DF4 lead related events [Up to 5 years]
Number of DF4 lead related events grouped by type
Bipolar pacing impedance (ohms) [5 years]
Summary statistics at 5 years post-implant will be reported.
High voltage impedance (ohms) [5 years]
Summary statistics at 5 years post-implant will be reported
Pacing threshold (volts) [5 years]
The pacing threshold is the minimum electrical stimulus needed to consistently depolarize the heart outside of the heart's refractory period. Summary statistics at 5 years post-implant will be reported.
Sensing amplitude (millivolts) [5 years]
The amplitude of the intrinsic cardiac electrical signals detected by electrodes on the defibrillator lead will be summarized at 5 years post-implant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Subject is intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application

Exclusion Criteria:

Subject who is, or will be inaccessible for follow-up at a study site
Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Anchorage	Alaska	United States
3	Gilbert	Arizona	United States
4	Scottsdale	Arizona	United States
5	Jonesboro	Arkansas	United States
6	Little Rock	Arkansas	United States
7	Bakersfield	California	United States
8	Chula Vista	California	United States
9	Rancho Mirage	California	United States
10	Salinas	California	United States
11	San Diego	California	United States
12	San Francisco	California	United States
13	Torrance	California	United States
14	Van Nuys	California	United States
15	Colorado Springs	Colorado	United States
16	Lakewood	Colorado	United States
17	Newark	Delaware	United States
18	Washington	District of Columbia	United States
19	Bradenton	Florida	United States
20	Clearwater	Florida	United States
21	Albany	Georgia	United States
22	Atlanta	Georgia	United States
23	Marietta	Georgia	United States
24	Indianapolis	Indiana	United States
25	Des Moines	Iowa	United States
26	Kansas City	Kansas	United States
27	Edgewood	Kentucky	United States
28	Louisville	Kentucky	United States
29	Baton Rouge	Louisiana	United States
30	Hyattsville	Maryland	United States
31	Takoma Park	Maryland	United States
32	Worcester	Massachusetts	United States
33	Lansing	Michigan	United States
34	Marquette	Michigan	United States
35	Robbinsdale	Minnesota	United States
36	Saint Louis Park	Minnesota	United States
37	Saint Paul	Minnesota	United States
38	Columbia	Missouri	United States
39	Kansas City	Missouri	United States
40	Saint Louis	Missouri	United States
41	Henderson	Nevada	United States
42	Morristown	New Jersey	United States
43	Albuquerque	New Mexico	United States
44	Garden City	New York	United States
45	Huntington	New York	United States
46	New York	New York	United States
47	Poughkeepsie	New York	United States
48	Utica	New York	United States
49	Durham	North Carolina	United States
50	Raleigh	North Carolina	United States
51	Winston-Salem	North Carolina	United States
52	Akron	Ohio	United States
53	Cincinnati	Ohio	United States
54	Cleveland	Ohio	United States
55	Toledo	Ohio	United States
56	Allentown	Pennsylvania	United States
57	Erie	Pennsylvania	United States
58	Lancaster	Pennsylvania	United States
59	Philadelphia	Pennsylvania	United States
60	Pittsburgh	Pennsylvania	United States
61	Germantown	Tennessee	United States
62	Kingsport	Tennessee	United States
63	Nashville	Tennessee	United States
64	Austin	Texas	United States
65	Plano	Texas	United States
66	The Woodlands	Texas	United States
67	Burlington	Vermont	United States
68	Olympia	Washington	United States
69	Spokane	Washington	United States
70	Tacoma	Washington	United States
71	Madison	Wisconsin	United States
72	Milwaukee	Wisconsin	United States
73	Calgary	Alberta	Canada
74	Kingston	Ontario	Canada
75	Montreal	Quebec	Canada
76	Quebec City	Quebec	Canada
77	Trois-Rivieres	Quebec	Canada
78	Nantes		France