PSR: Product Surveillance Registry

Sponsor

Medtronic (Industry)

Overall Status

Recruiting

CT.gov ID

NCT01524276

Collaborator

(none)

100,000

Enrollment

382

Locations

216

Duration (Months)

261.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Rhythm Disorders Urological Disorders Neurological Disorders Cardiovascular Disorders Digestive Disorders Intracranial Aneurysm Mechanical Circulatory Support Respiratory Therapy Aortic, Peripheral Vascular and Venous Disorders Minimally Invasive Surgical Procedures Diagnostic Techniques and Procedures Surgical Procedures, Operative Renal Insufficiency Neurovascular Coronary Artery Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

100000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Medtronic Product Surveillance Registry

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2030

Anticipated Study Completion Date :

Jan 1, 2030

Outcome Measures

Primary Outcome Measures

Safety and Effectiveness of Market Released products [Every 6-12 months (Therapy-dependent)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive or be treated with an eligible Medtronic product
Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

Patient who is, or will be, inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Huntsville	Alabama	United States
3	Anchorage	Alaska	United States
4	Chandler	Arizona	United States
5	Phoenix	Arizona	United States
6	Jonesboro	Arkansas	United States
7	Little Rock	Arkansas	United States
8	Aliso Viejo	California	United States
9	Bakersfield	California	United States
10	Chula Vista	California	United States
11	Los Angeles	California	United States
12	Napa	California	United States
13	Palm Springs	California	United States
14	Rancho Mirage	California	United States
15	Redwood City	California	United States
16	Salinas	California	United States
17	San Diego	California	United States
18	San Francisco	California	United States
19	Stanford	California	United States
20	Torrance	California	United States
21	Van Nuys	California	United States
22	Ventura	California	United States
23	Aurora	Colorado	United States
24	Centennial	Colorado	United States
25	Colorado Springs	Colorado	United States
26	Denver	Colorado	United States
27	Lakewood	Colorado	United States
28	New Haven	Connecticut	United States
29	Washington	District of Columbia	United States
30	Bradenton	Florida	United States
31	Clearwater	Florida	United States
32	Hollywood	Florida	United States
33	Jacksonville	Florida	United States
34	Merritt Island	Florida	United States
35	Miami	Florida	United States
36	Orlando	Florida	United States
37	Panama City	Florida	United States
38	Safety Harbor	Florida	United States
39	Tampa	Florida	United States
40	Albany	Georgia	United States
41	Atlanta	Georgia	United States
42	Marietta	Georgia	United States
43	Chicago	Illinois	United States
44	Maywood	Illinois	United States
45	Oak Lawn	Illinois	United States
46	Evansville	Indiana	United States
47	Indianapolis	Indiana	United States
48	Iowa City	Iowa	United States
49	West Des Moines	Iowa	United States
50	Kansas City	Kansas	United States
51	Edgewood	Kentucky	United States
52	Louisville	Kentucky	United States
53	Baton Rouge	Louisiana	United States
54	New Orleans	Louisiana	United States
55	Shreveport	Louisiana	United States
56	Baltimore	Maryland	United States
57	Clinton	Maryland	United States
58	Hyattsville	Maryland	United States
59	Salisbury	Maryland	United States
60	Silver Spring	Maryland	United States
61	Takoma Park	Maryland	United States
62	Boston	Massachusetts	United States
63	Ann Arbor	Michigan	United States
64	Detroit	Michigan	United States
65	Lansing	Michigan	United States
66	Marquette	Michigan	United States
67	Rochester Hills	Michigan	United States
68	Royal Oak	Michigan	United States
69	Ypsilanti	Michigan	United States
70	Coon Rapids	Minnesota	United States
71	Minneapolis	Minnesota	United States
72	Robbinsdale	Minnesota	United States
73	Rochester	Minnesota	United States
74	Saint Cloud	Minnesota	United States
75	Saint Paul	Minnesota	United States
76	Hattiesburg	Mississippi	United States
77	Columbia	Missouri	United States
78	Kansas City	Missouri	United States
79	Saint Louis	Missouri	United States
80	Omaha	Nebraska	United States
81	Camden	New Jersey	United States
82	Morristown	New Jersey	United States
83	New Brunswick	New Jersey	United States
84	Ocean Township	New Jersey	United States
85	Ridgewood	New Jersey	United States
86	Teaneck	New Jersey	United States
87	Albuquerque	New Mexico	United States
88	Albany	New York	United States
89	Huntington	New York	United States
90	Manhasset	New York	United States
91	New York	New York	United States
92	Poughkeepsie	New York	United States
93	Staten Island	New York	United States
94	Utica	New York	United States
95	Valhalla	New York	United States
96	Chapel Hill	North Carolina	United States
97	Durham	North Carolina	United States
98	Raleigh	North Carolina	United States
99	Winston-Salem	North Carolina	United States
100	Akron	Ohio	United States
101	Cincinnati	Ohio	United States
102	Cleveland	Ohio	United States
103	Columbus	Ohio	United States
104	Dayton	Ohio	United States
105	Fairlawn	Ohio	United States
106	Mount Orab	Ohio	United States
107	Toledo	Ohio	United States
108	Oklahoma City	Oklahoma	United States
109	Tulsa	Oklahoma	United States
110	Portland	Oregon	United States
111	Allentown	Pennsylvania	United States
112	Bethlehem	Pennsylvania	United States
113	Danville	Pennsylvania	United States
114	Erie	Pennsylvania	United States
115	Harrisburg	Pennsylvania	United States
116	Hershey	Pennsylvania	United States
117	Lancaster	Pennsylvania	United States
118	Philadelphia	Pennsylvania	United States
119	Pittsburgh	Pennsylvania	United States
120	Wilkes-Barre	Pennsylvania	United States
121	Columbia	South Carolina	United States
122	Greenville	South Carolina	United States
123	Orangeburg	South Carolina	United States
124	Spartanburg	South Carolina	United States
125	Sioux Falls	South Dakota	United States
126	Germantown	Tennessee	United States
127	Nashville	Tennessee	United States
128	Austin	Texas	United States
129	Dallas	Texas	United States
130	Fort Worth	Texas	United States
131	Houston	Texas	United States
132	Plano	Texas	United States
133	The Woodlands	Texas	United States
134	Tyler	Texas	United States
135	Salt Lake City	Utah	United States
136	Burlington	Vermont	United States
137	Charlottesville	Virginia	United States
138	Norfolk	Virginia	United States
139	Richmond	Virginia	United States
140	Bremerton	Washington	United States
141	Seattle	Washington	United States
142	Spokane	Washington	United States
143	Madison	Wisconsin	United States
144	Milwaukee	Wisconsin	United States
145	Buenos Aires		Argentina
146	Chermside		Australia
147	Murdoch		Australia
148	Southport		Australia
149	Brugge		Belgium
150	Brussel		Belgium
151	Charleroi		Belgium
152	Edegem		Belgium
153	Genk		Belgium
154	Gent		Belgium
155	Liege		Belgium
156	Roeselare		Belgium
157	Sint-Niklaas		Belgium
158	Wilrijk		Belgium
159	Yvoir		Belgium
160	São Paulo		Brazil
161	Calgary	Alberta	Canada
162	Kingston	Ontario	Canada
163	London	Ontario	Canada
164	Montreal	Quebec	Canada
165	Quebec City		Canada
166	Quebec		Canada
167	Toronto		Canada
168	Santiago		Chile
169	Beijing		China
170	Changsha		China
171	Chongqing		China
172	Guangzhou		China
173	Kunming		China
174	Taiyuan		China
175	Tianjin		China
176	Yancheng		China
177	Bogota		Colombia
178	Medellin		Colombia
179	Pereira		Colombia
180	Rionegro		Colombia
181	Praha		Czechia
182	Arhus		Denmark
183	Copenhagen		Denmark
184	Hellerup		Denmark
185	Hillerød		Denmark
186	Kobenhavn		Denmark
187	Odense		Denmark
188	Århus N		Denmark
189	Turku		Finland
190	Avignon		France
191	Bayonne		France
192	Besançon		France
193	Bordeaux		France
194	Brest Cedex		France
195	Bron		France
196	Caen		France
197	Chambray		France
198	Clermont Ferrand		France
199	Créteil		France
200	Dijon		France
201	La Rochelle		France
202	La Tronche		France
203	Le Kremlin-Bicêtre		France
204	Lille		France
205	Limoges		France
206	Marseille		France
207	Montpellier		France
208	Nantes		France
209	Neuilly		France
210	Paris		France
211	Pessac		France
212	Pringy		France
213	Rennes		France
214	Rouen		France
215	Saint Priest		France
216	Strasbourg		France
217	Toulouse		France
218	Vandœuvre-lès-Nancy		France
219	Villeurbanne		France
220	Aachen		Germany
221	Augsburg		Germany
222	Bad Krozingen		Germany
223	Dresden		Germany
224	Erlangen		Germany
225	Essen		Germany
226	Freiburg		Germany
227	Hamburg		Germany
228	Hannover		Germany
229	Heidelberg		Germany
230	Heilbronn		Germany
231	Homburg		Germany
232	Jena		Germany
233	Karlsruhe		Germany
234	Koln		Germany
235	Leipzig		Germany
236	Mannheim		Germany
237	Munster		Germany
238	München		Germany
239	Regensburg		Germany
240	Stuttgart		Germany
241	Ulm		Germany
242	Villingen-Schwenningen		Germany
243	Athens		Greece
244	Maroúsi		Greece
245	Hong Kong		Hong Kong
246	Budapest		Hungary
247	Reykjavik		Iceland
248	Chennai		India
249	Ashkelon		Israel
250	Jerusalem		Israel
251	Ramat Gan		Israel
252	Tel HaShomer		Israel
253	Ancona		Italy
254	Bari		Italy
255	Bologna		Italy
256	Brescia		Italy
257	Castrovillari		Italy
258	Cotignola		Italy
259	Firenze		Italy
260	Lecce		Italy
261	Milano		Italy
262	Palermo		Italy
263	Pavia		Italy
264	Pisa		Italy
265	Udine		Italy
266	Chiba		Japan
267	Fuchū		Japan
268	Fukuoka		Japan
269	Hirosaki		Japan
270	Hiroshima City		Japan
271	Itabashi		Japan
272	Kawasaki		Japan
273	Kitakyushu		Japan
274	Kyoto		Japan
275	Mitaka		Japan
276	Nagoya		Japan
277	Nerima-Ku		Japan
278	Okayama		Japan
279	Shinagawa-Ku		Japan
280	Shinjuku-Ku		Japan
281	Suita		Japan
282	Toyoake		Japan
283	Urasoe		Japan
284	Yamagata		Japan
285	Yokohama		Japan
286	Ōsaka-sayama		Japan
287	Busan		Korea, Republic of
288	Changwon		Korea, Republic of
289	Daegu		Korea, Republic of
290	Gangneung		Korea, Republic of
291	Gwangju		Korea, Republic of
292	Gyeonggi-do		Korea, Republic of
293	Incheon		Korea, Republic of
294	Jeonju		Korea, Republic of
295	Seongnam-si		Korea, Republic of
296	Seoul		Korea, Republic of
297	Hadiya		Kuwait
298	Kuala Lumpur		Malaysia
299	Ciudad de mexico		Mexico
300	Amsterdam		Netherlands
301	Breda		Netherlands
302	Den Haag		Netherlands
303	Eindhoven		Netherlands
304	Enschede		Netherlands
305	Groningen		Netherlands
306	Heerlen		Netherlands
307	Leiden		Netherlands
308	Maastricht		Netherlands
309	Nieuwegein		Netherlands
310	Rotterdam		Netherlands
311	Bergen		Norway
312	Lørenskog		Norway
313	Trondheim		Norway
314	Poznań		Poland
315	Warszawa		Poland
316	Zabrze		Poland
317	Carnaxide		Portugal
318	Creixomil		Portugal
319	Lisboa		Portugal
320	Porto		Portugal
321	Santarém		Portugal
322	Vila Nova De Gaia		Portugal
323	Aibonito		Puerto Rico
324	Rio Piedras		Puerto Rico
325	Moscow		Russian Federation
326	Novosibirsk		Russian Federation
327	Saint Petersburg		Russian Federation
328	Jeddah		Saudi Arabia
329	Riyadh		Saudi Arabia
330	Belgrade		Serbia
331	Bratislava		Slovakia
332	Košice		Slovakia
333	Ljubljana		Slovenia
334	Johannesburg		South Africa
335	A Coruña		Spain
336	Badalona		Spain
337	Barakaldo		Spain
338	Barcelona		Spain
339	Granada		Spain
340	L'Hospitalet De Llobregat		Spain
341	Madrid		Spain
342	Oviedo		Spain
343	Palma De Mallorca		Spain
344	Salamanca		Spain
345	San Sebastián		Spain
346	Santa Cruz De Tenerife		Spain
347	Santiago De Compostela		Spain
348	Sevilla		Spain
349	Toledo		Spain
350	Valladolid		Spain
351	Vigo		Spain
352	Vitoria		Spain
353	Skövde		Sweden
354	Uppsala		Sweden
355	Basel		Switzerland
356	Bern		Switzerland
357	Fribourg		Switzerland
358	Geneve		Switzerland
359	Lausanne		Switzerland
360	Lugano		Switzerland
361	Morges		Switzerland
362	Nottwil		Switzerland
363	Zürich		Switzerland
364	Abu Dhabi		United Arab Emirates
365	Barnstaple		United Kingdom
366	Birmingham		United Kingdom
367	Blackpool		United Kingdom
368	Bristol		United Kingdom
369	Chelmsford		United Kingdom
370	Glasgow		United Kingdom
371	Leeds		United Kingdom
372	Leicester		United Kingdom
373	Liverpool		United Kingdom
374	London		United Kingdom
375	Manchester		United Kingdom
376	Middlesbrough		United Kingdom
377	Newcastle Upon Tyne		United Kingdom
378	Northampton		United Kingdom
379	Romford		United Kingdom
380	Sheffield		United Kingdom
381	Southampton		United Kingdom
382	Stoke-on-Trent		United Kingdom