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

Stereotaxis

Status and phase

Terminated

Phase 4

Conditions

Heart Failure, Congestive

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00370526

PM-CLIN 008

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria