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Neuromodulation Device
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure (DEFEAT-HF Trial)
Phase 2
Waitlist Available
Led By Heinz Theres, M.D.
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.
Eligible Conditions
- Congestive Heart Failure
- Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2015 Phase 2 trial • 81 Patients • NCT0111257929%
Decompensated Heart Failure
13%
Ventricular Tachycardia
13%
Pneumonia
13%
Device Stimulation Issue
13%
Dyspnoea
8%
Orthostatic Hypotension
8%
Adverse Drug Reaction
8%
Cardiogenic Shock
8%
Fatigue
8%
Pain in Extremity
8%
Dizziness
8%
Skin Reaction
4%
Vomiting
4%
Syncope
4%
Pancreatitis
4%
Atrial Tachycardia
4%
Cardiac Perforation
4%
Pericardial Effusion
4%
Pancreatic Cyst
4%
Device Extrusion
4%
Device Lead Damage
4%
Sudden Death
4%
Clostridium Difficile Colitis
4%
Gastroenteritis
4%
Pericarditis Infective
4%
Upper Respiratory Tract Infection
4%
Urinary Tract Infection
4%
Gout
4%
Hypokalaemia
4%
Gallbladder Neoplasm
4%
Epilepsy
4%
Renal Failure
4%
Apnoea
4%
Haematoma
4%
Peripheral Arterial Occlusive Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medtronic PrimeADVANCED Neurostimulator
2010
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
205 Previous Clinical Trials
136,738 Total Patients Enrolled
Heinz Theres, M.D.Principal InvestigatorCharite Universitatsmedizin Berlin - Campus Charite Mitte
Douglas P Zipes, M.D.Principal InvestigatorKrannert Institute of Cardiology