NCT00370526

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stereotaxis · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure, Congestive

Interventions

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

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-04-01
• Completion: 2007-12-01
• First posted: 2006-08-31
• Last updated: 2008-01-11

Locations

5 sites across 3 countries: United States, Canada, Italy