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Neuromodulation Device

Control for 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

Summary

The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 2 trial • 81 Patients • NCT01112579
29%
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

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
201 Previous Clinical Trials
130,005 Total Patients Enrolled
79 Trials studying Heart Failure
65,828 Patients Enrolled for Heart Failure
Heinz Theres, M.D.Principal InvestigatorCharite Universitatsmedizin Berlin - Campus Charite Mitte
Douglas P Zipes, M.D.Principal InvestigatorKrannert Institute of Cardiology
~5 spots leftby Sep 2025
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