InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Completed

CT.gov ID

NCT00289302

Collaborator

(none)

600

Enrollment

Locations

Duration (Months)

11.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm. The InSync ICD device can change the timing of when the left and right ventricles of the heart are paced to beat.

The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Cardiomyopathy	Device: Cardiac resynchronization therapy device

Study Design

Study Type:

Observational

Observational Model:

Defined Population

Time Perspective:

Prospective

Official Title:

InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy

Study Start Date :

Jan 1, 2003

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients implanted with the InSync ICD or InSync Marquis cardiac resynchronization therapy (CRT) system (includes InSync ICD Model 7272 or InSync Marquis Model 7277, right atrial lead, right ventricular lead and any market released Medtronic left ventricular lead or the investigational Attain Model 4189 lead which was implanted during the MIRACLE ICD Study)

Exclusion Criteria:

Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync ICD Registry

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	Mobile	Alabama	United States
3	Phoenix	Arizona	United States
4	San Diego	California	United States
5	Stanford	California	United States
6	New Haven	Connecticut	United States
7	Newark	Delaware	United States
8	Jacksonville	Florida	United States
9	Miami	Florida	United States
10	Orlando	Florida	United States
11	Palm Beach Gardens	Florida	United States
12	St. Petersburg	Florida	United States
13	Atlanta	Georgia	United States
14	Chicago	Illinois	United States
15	Oak Lawn	Illinois	United States
16	Indianapolis	Indiana	United States
17	Davenport	Iowa	United States
18	Des Moines	Iowa	United States
19	Topeka	Kansas	United States
20	Lexington	Kentucky	United States
21	Baton Rouge	Louisiana	United States
22	Houma	Louisiana	United States
23	New Orleans	Louisiana	United States
24	Baltimore	Maryland	United States
25	Boston	Massachusetts	United States
26	Burlington	Massachusetts	United States
27	Rochester	Minnesota	United States
28	St. Louis	Missouri	United States
29	Las Vegas	Nevada	United States
30	Cherry Hill	New Jersey	United States
31	Hackensack	New Jersey	United States
32	Albany	New York	United States
33	Chapel Hill	North Carolina	United States
34	Raleigh	North Carolina	United States
35	Cincinnati	Ohio	United States
36	Cleveland	Ohio	United States
37	Columbus	Ohio	United States
38	Mayfield Heights	Ohio	United States
39	Oklahoma City	Oklahoma	United States
40	Erie	Pennsylvania	United States
41	Lancaster	Pennsylvania	United States
42	Providence	Rhode Island	United States
43	Spartanburg	South Carolina	United States
44	Memphis	Tennessee	United States
45	Austin	Texas	United States
46	Dallas	Texas	United States
47	Salt Lake City	Utah	United States
48	Richmond	Virginia	United States
49	Seattle	Washington	United States
50	Spokane	Washington	United States
51	Milwaukee	Wisconsin	United States