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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

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.

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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.

Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No