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

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00370526
• Other study ID #: PM-CLIN 008
• Status: Terminated
• Phase: Phase 4
• First received: August 29, 2006
• Last updated: January 2, 2008
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

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

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Italy	San Raffaele University Hospital	Milan
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northeast Georgia Heart Center, PC	Gainesville	Georgia
United States	Medical College of Virginia - Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Stereotaxis	Medtronic

Countries where clinical trial is conducted

United States,  Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in end systolic volume (ESV)		6 months
Secondary	New York Heart Association (NYHA) Class		6 months
Secondary	6 minute walk		6 months
Secondary	Quality of life (QoL)		6 months
Secondary	Cardiac-related mortality		6 months
Secondary	HF-related hospitalizations		6 months