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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00370526

Enrollment

100

Registered

2006-08-31

Start date

2007-02-28

Completion date

2007-12-31

Last updated

2008-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

heart failure, resynchronization, CRT, Bi-V pacemaker, LV lead placement, hemodynamic assessment, CRT Outcomes

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction in end systolic volume (ESV)	6 months

Secondary

Measure	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

Countries

Canada, Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026