NL-OMON36274CompletedNot Applicable
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure - DEFEAT-HF
Medtronic Trading NL BV0 sites10 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
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)
Investigators
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