Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

Completed

Conditions: chronic heart failure
failing pumpfunction of the heart
10019280

Registration Number: NL-OMON36274

Lead Sponsor: Medtronic Trading NL BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• LVEF of 35% or less
• NYHA functional Class III
• QRS duration less than 120 ms
• LVEDD of 55 mm - 80 mm
• Receiving stable medical therapy for heart failure prior to enrollment.
(see p15)

Exclusion Criteria

• Temporal stop of anticoagulation therapy poses an unacceptable health risk
• Inability to perform an exercise capacity test
• Pregnancy or likely to get pregant during the course of the study
• CABG/PCI/BMS procedures within the past 90 days
• Heart transplant
• Acute Coronary Syndrome within the past 90 days
• Congenital heart disease with significant hemodynamic shunting
• Reversible cardiomyopathy (i.e. tachycardia induced heart failure)
• Diagnosed unstable angina pectoris
• Unstable coronary artery disease
• CRT device implanted
• non-Medtronic ICD, pacemaker or defibrillation lead
• Patient already has a neurostimulator
(see p15-16)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences between the treatment group and the control group regarding:<br /><br><br /><br>• Reduction of the left ventricle after 6 months of spinal cord stimulation (as<br /><br>measured with echo: LVESVi)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Treatment group vs control group diferences in:<br /><br>• Biomarkers from blood sampling (e.g. ProBNP, BNP, cathecholamines, BUN,<br /><br>creatinine)<br /><br>• Maximal oxygen uptake<br /><br>• Quality of life</p><br>