HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study

Stopped early · Phase 4

Conditions studied: Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00370526

Run by

Stereotaxis

People needed

100

Starts

2007-02-01

Expected to finish

2007-12-01

Last updated by the study team

2008-01-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northeast Georgia Heart Center, PC — Gainesville, Georgia, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Medical College of Virginia - Virginia Commonwealth University — Richmond, Virginia, United States
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada
• San Raffaele University Hospital — Milan, Italy

Full record on ClinicalTrials.gov

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