PPR: Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

Sponsor

Medtronic (Industry)

Overall Status

Recruiting

CT.gov ID

NCT00271180

Collaborator

(none)

20,000

Enrollment

244

Locations

695

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia Bradycardia Heart Failure Sinus Tachycardia	Device: Device

Detailed Description

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Medtronic CRDM Product Performance Report

Study Start Date :

Jan 1, 1983

Anticipated Primary Completion Date :

Dec 1, 2040

Anticipated Study Completion Date :

Dec 1, 2040

Outcome Measures

Primary Outcome Measures

Lead related complications for each lead model. [Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive).]
All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria:

• Subject 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 must also apply:

Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data

Exclusion Criteria:

Subjects who are, or will be inaccessible for follow-up
Subjects with exclusion criteria required by local law (EMEA only)
Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Anchorage	Alaska	United States
3	Chandler	Arizona	United States
4	Jonesboro	Arkansas	United States
5	Little Rock	Arkansas	United States
6	Bakersfield	California	United States
7	Chula Vista	California	United States
8	Los Angeles	California	United States
9	Rancho Mirage	California	United States
10	Redwood City	California	United States
11	Salinas	California	United States
12	San Diego	California	United States
13	Stanford	California	United States
14	Torrance	California	United States
15	Van Nuys	California	United States
16	Ventura	California	United States
17	Centennial	Colorado	United States
18	Colorado Springs	Colorado	United States
19	Lakewood	Colorado	United States
20	New Haven	Connecticut	United States
21	Washington	District of Columbia	United States
22	Bradenton	Florida	United States
23	Clearwater	Florida	United States
24	Hollywood	Florida	United States
25	Jacksonville	Florida	United States
26	Panama City	Florida	United States
27	Safety Harbor	Florida	United States
28	Atlanta	Georgia	United States
29	Marietta	Georgia	United States
30	Evansville	Indiana	United States
31	Indianapolis	Indiana	United States
32	West Des Moines	Iowa	United States
33	Kansas City	Kansas	United States
34	Edgewood	Kentucky	United States
35	Louisville	Kentucky	United States
36	Baton Rouge	Louisiana	United States
37	Shreveport	Louisiana	United States
38	Bethesda	Maryland	United States
39	Clinton	Maryland	United States
40	Hyattsville	Maryland	United States
41	Salisbury	Maryland	United States
42	Silver Spring	Maryland	United States
43	Takoma Park	Maryland	United States
44	Boston	Massachusetts	United States
45	Lansing	Michigan	United States
46	Marquette	Michigan	United States
47	Ypsilanti	Michigan	United States
48	Coon Rapids	Minnesota	United States
49	Minneapolis	Minnesota	United States
50	Robbinsdale	Minnesota	United States
51	Rochester	Minnesota	United States
52	Saint Cloud	Minnesota	United States
53	Saint Paul	Minnesota	United States
54	Hattiesburg	Mississippi	United States
55	Columbia	Missouri	United States
56	Kansas City	Missouri	United States
57	Saint Louis	Missouri	United States
58	Morristown	New Jersey	United States
59	Ocean City	New Jersey	United States
60	Ridgewood	New Jersey	United States
61	Albuquerque	New Mexico	United States
62	Huntington	New York	United States
63	Manhasset	New York	United States
64	New York	New York	United States
65	Poughkeepsie	New York	United States
66	Utica	New York	United States
67	Durham	North Carolina	United States
68	Raleigh	North Carolina	United States
69	Akron	Ohio	United States
70	Cincinnati	Ohio	United States
71	Cleveland	Ohio	United States
72	Columbus	Ohio	United States
73	Toledo	Ohio	United States
74	Oklahoma City	Oklahoma	United States
75	Portland	Oregon	United States
76	Allentown	Pennsylvania	United States
77	Bethlehem	Pennsylvania	United States
78	Danville	Pennsylvania	United States
79	Erie	Pennsylvania	United States
80	Lancaster	Pennsylvania	United States
81	Philadelphia	Pennsylvania	United States
82	Pittsburgh	Pennsylvania	United States
83	Wilkes-Barre	Pennsylvania	United States
84	Columbia	South Carolina	United States
85	Germantown	Tennessee	United States
86	Nashville	Tennessee	United States
87	Austin	Texas	United States
88	Dallas	Texas	United States
89	Fort Worth	Texas	United States
90	Houston	Texas	United States
91	Plano	Texas	United States
92	The Woodlands	Texas	United States
93	Tyler	Texas	United States
94	Burlington	Vermont	United States
95	Charlottesville	Virginia	United States
96	Olympia	Washington	United States
97	Spokane	Washington	United States
98	Madison	Wisconsin	United States
99	Milwaukee	Wisconsin	United States
100	Chermside		Australia
101	Murdoch		Australia
102	Brussel		Belgium
103	Edegem		Belgium
104	Leuven		Belgium
105	Liège		Belgium
106	Calgary		Canada
107	Kingston		Canada
108	Montreal		Canada
109	Québec		Canada
110	Changsha		China
111	Kunming		China
112	Taiyuan		China
113	Tianjin		China
114	Praha		Czechia
115	Hellerup		Denmark
116	Hillerød		Denmark
117	Odense		Denmark
118	Århus		Denmark
119	Avignon		France
120	Bayonne		France
121	Brest		France
122	Caen		France
123	Chambray-lès-Tours		France
124	Clermont-Ferrand		France
125	Dijon		France
126	La Rochelle		France
127	La Tronche		France
128	Lille		France
129	Montpellier		France
130	Nantes		France
131	Neuilly-sur-Seine		France
132	Paris		France
133	Pessac		France
134	Pringy		France
135	Rennes		France
136	Saint-Priest-en-Jarez		France
137	Strasbourg		France
138	Toulouse		France
139	Vandoeuvre les Nancy		France
140	Villeurbanne		France
141	Aachen		Germany
142	Dresden		Germany
143	Düsseldorf		Germany
144	Essen		Germany
145	Hamburg		Germany
146	Hannover		Germany
147	Heidelberg		Germany
148	Homburg		Germany
149	Jena		Germany
150	Köln		Germany
151	München		Germany
152	Münster		Germany
153	Tübingen		Germany
154	Ulm		Germany
155	Athens		Greece
156	Marousi		Greece
157	Budapest		Hungary
158	Reykjavik		Iceland
159	Ashkelon		Israel
160	Jerusalem		Israel
161	Ramat Gan		Israel
162	Bari		Italy
163	Bologna		Italy
164	Brescia		Italy
165	Castrovillari		Italy
166	Cotignola		Italy
167	Lecce		Italy
168	Milano		Italy
169	Pisa		Italy
170	Udine		Italy
171	Hiroshima City		Japan
172	Kawasaki		Japan
173	Kitakyushu		Japan
174	Kyoto		Japan
175	Mitaka		Japan
176	Nagoya		Japan
177	Okayama		Japan
178	Shinagawa-Ku		Japan
179	Suita		Japan
180	Tokyo		Japan
181	Toyoake		Japan
182	Urasoe		Japan
183	Yokohama		Japan
184	Ōsaka-sayama		Japan
185	Gyeonggi-do		Korea, Republic of
186	Seoul		Korea, Republic of
187	Hadiya		Kuwait
188	Kuala Lumpur		Malaysia
189	Amsterdam		Netherlands
190	Breda		Netherlands
191	Den Haag		Netherlands
192	Eindhoven		Netherlands
193	Enschede		Netherlands
194	Groningen		Netherlands
195	Leiden		Netherlands
196	Maastricht		Netherlands
197	Nieuwegein		Netherlands
198	Rotterdam		Netherlands
199	Bergen		Norway
200	Trondheim		Norway
201	Poznań		Poland
202	Zabrze		Poland
203	Carnaxide		Portugal
204	Creixomil		Portugal
205	Lisboa		Portugal
206	Porto		Portugal
207	Santarém		Portugal
208	Jeddah		Saudi Arabia
209	Riyadh		Saudi Arabia
210	Belgrade		Serbia
211	Ljubljana		Slovenia
212	A Coruña		Spain
213	Barcelona		Spain
214	Granada		Spain
215	Madrid		Spain
216	Palma De Mallorca		Spain
217	Salamanca		Spain
218	Santa Cruz De Tenerife		Spain
219	Santiago de Compostela		Spain
220	Toledo		Spain
221	Valladolid		Spain
222	Vitoria-Gasteiz		Spain
223	Skövde		Sweden
224	Uppsala		Sweden
225	Basel		Switzerland
226	Bern		Switzerland
227	Fribourg		Switzerland
228	Geneva		Switzerland
229	Lausanne		Switzerland
230	Lugano		Switzerland
231	Zürich		Switzerland
232	Birmingham		United Kingdom
233	Blackpool		United Kingdom
234	Bristol		United Kingdom
235	Leeds		United Kingdom
236	Leicester		United Kingdom
237	Liverpool		United Kingdom
238	London		United Kingdom
239	Manchester		United Kingdom
240	Middlesbrough		United Kingdom
241	Northampton		United Kingdom
242	Nottingham		United Kingdom
243	Sheffield		United Kingdom
244	Southampton		United Kingdom