PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Completed

CT.gov ID

NCT00253357

Collaborator

Medtronic (Industry)

450

Enrollment

Locations

Duration (Months)

16.1

Patients Per Site

0.6

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. Using a medical device like a pacemaker or a defibrillator can help the heart to pump in regular beats. However, not all patients do better with a device. Currently, there is not a way to identify which patients will benefit from the device. The purpose of this study is to determine if using medical tests, Echocardiogram, can help in predicting which patients will improve. The types of patients needed for this study are those who have been diagnosed with moderate or severe heart failure.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Congestive Heart Failure Cardiomyopathy

Study Design

Study Type:

Observational

Time Perspective:

Prospective

Official Title:

Predictors of Response to Cardiac Re-Synchronization Therapy

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Jun 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:

Moderate to severe heart failure
Ejection Fraction ( measurement of blood pumped out of the heart) less than 35%
Wide (greater than 130 milliseconds) QRS duration for US patients only.
May include patients with less than 130 millisecond QRS duration if they have mechanical dyssynochrony (uncoordinated heart contractions) in Europe.
All patients enrolled should be stable on medications that include at least an ACE inhibitor or Angiotensin Receptor Blocker (ARB) and at optimal level for at least one month prior to surgery

Exclusion Criteria:

Patients that are not eligible for this study are those that have a mechanical right heart valve or are experiencing the following medical conditions within the last 3 months:
Chest pain / unstable angina
Acute heart attack
Chronic or permanent atrial arrhythmias such as atrial fibrillation
Contrary artery bypass graft (CABG)
Percutaneous transluminal coronary angioplasty (PTCA)
Patients who have had intermittent or continuous Inotropic drug therapy are not eligible for this study.
Patients who have had heart transplant or a prior Cardiac Resynchronization Therapy device are not eligible for this study.
Patients who are pregnant or are of child-bearing potential are not on a form of birth control may not participate in this study.

Contacts and Locations

Locations

	City	State	Country
1	Several locations	California	United States
2	Gainsville	Florida	United States
3	Atlanta	Georgia	United States
4	Columbus	Illinois	United States
5	Kansas City	Kansas	United States
6	New Orleans	Louisiana	United States
7	Grand Rapids	Michigan	United States
8	Several locations	New Jersey	United States
9	Several locations	New York	United States
10	Winston-Salem	North Carolina	United States
11	Several locations	Ohio	United States
12	Dolyestown	Pennsylvania	United States
13	Nashville	Tennessee	United States
14	Burlington	Vermont	United States
15	Norfolk	Virginia	United States
16	Seattle	Washington	United States
17	Several locations		Austria
18	Several locations		Belgium
19	Several locations		Denmark
20	Several locations		Finland
21	Several locations		France
22	Several locations		Germany
23	Several locations		Hong Kong
24	Several locations		Italy
25	Several locations		Netherlands
26	Several locations		Norway
27	Several locations		Spain
28	Several locations		United Kingdom