Status:
TERMINATED
HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
Lead Sponsor:
Stereotaxis
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit fr...
Detailed Description
Baseline information will be obtained including QoL, 6-minute walk, and echo measurements. The patient will be randomized to receive a conventionally-placed LV lead or randomized to receive a magnetic...
Eligibility Criteria
Inclusion
- Ischemic cardiomyopathy
- Ejection Fraction (EF) \<= 35%
- QRS duration \>= 120 msec
- Standard heart failure (HF) oral medications for at least 1 month
- Evidence of mechanical dyssynchrony
- NYHA Class III or IV
Exclusion
- Persistent or chronic atrial fibrillation (AF)
- Hemodynamically unstable or uncontrolled arrhythmias
- Unstable angina
- Aortic valve (AV) insufficiency or stenosis
- Mitral valve (MV) regurgitation \> 2+
- Active infection
- Contraindications for heparin
- Dependence on atrial pacing
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00370526
Start Date
February 1 2007
End Date
December 1 2007
Last Update
January 11 2008
Active Locations (5)
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1
Northeast Georgia Heart Center, PC
Gainesville, Georgia, United States, 30501
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
Medical College of Virginia - Virginia Commonwealth University
Richmond, Virginia, United States, 23129
4
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7