Clinical trial NCT00370526: HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study
Official title: HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Keywords: heart failure
resynchronization
CRT
Bi-V pacemaker
LV lead placement
hemodynamic assessment
CRT Outcomes
Lead sponsor: Stereotaxis
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Reduction in end systolic volume (ESV)
timeFrame: 6 months
Secondary outcomes:
measure: New York Heart Association (NYHA) Class
timeFrame: 6 months
measure: 6 minute walk
timeFrame: 6 months
measure: Quality of life (QoL)
timeFrame: 6 months
measure: Cardiac-related mortality
timeFrame: 6 months
measure: HF-related hospitalizations
timeFrame: 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center, PC
state: Georgia
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Richmond
country: United States
facility: Medical College of Virginia - Virginia Commonwealth University
state: Virginia
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Milan
country: Italy
facility: San Raffaele University Hospital
Study officials:
affiliation: San Raffaele University Hospital
name: Carlo Pappone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: