HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00370526
- Lead Sponsor
- Stereotaxis
- 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 from the device. The HEAL-HF protocol will compare the outcomes of conventionally placed CRT devices with magnetically placed CRT devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.
- 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 magnetically-placed LV lead. The magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing. Patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in HF symptoms. Adverse events will also be recorded during the follow-up period.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in end systolic volume (ESV) 6 months
- Secondary Outcome Measures
Name Time Method Quality of life (QoL) 6 months Cardiac-related mortality 6 months 6 minute walk 6 months New York Heart Association (NYHA) Class 6 months HF-related hospitalizations 6 months
Trial Locations
- Locations (5)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Northeast Georgia Heart Center, PC
🇺🇸Gainesville, Georgia, United States
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
San Raffaele University Hospital
🇮🇹Milan, Italy
Medical College of Virginia - Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States