Status:
COMPLETED
PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure
Congestive Heart Failure
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
End Date :
June 1 2006
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00253357
Start Date
March 1 2004
End Date
June 1 2006
Last Update
December 21 2007
Active Locations (28)
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1
Several Locations, California, United States
2
Gainsville, Florida, United States
3
Atlanta, Georgia, United States
4
Columbus, Illinois, United States