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

Study Overview
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Brief Summary
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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
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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.

Official Title
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HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Procedure: Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in end systolic volume (ESV) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Heart Association (NYHA) Class |  | 6 months | 
| 6 minute walk |  | 6 months | 
| Quality of life (QoL) |  | 6 months | 
| Cardiac-related mortality |  | 6 months | 
| HF-related hospitalizations |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT, heart failure, resynchronization, Bi-V pacemaker, LV lead placement, hemodynamic assessment, CRT Outcomes