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Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure (DEFEAT-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Medtronic PrimeADVANCED Neurostimulator
Medtronic PrimeADVANCED Neurostimulator
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
  • New York Heart Association (NYHA) functional Class III at time of screening
  • QRS duration less than 120 milliseconds (ms)
  • Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
  • Receiving stable optimal medical therapy for heart failure prior to enrollment
  • Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
  • 18 years of age or older
  • Willing and able to comply with study procedures
  • Expected lifespan greater than 12 months beyond study enrollment as assessed by physician

Exclusion Criteria:

  • Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
  • Polyneuropathy
  • Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
  • Unable to perform an exercise capacity test
  • Pregnant or planning to become pregnant during this study
  • Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
  • Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
  • Had a heart transplant
  • Has complete heart block
  • Had Acute Coronary Syndrome within the past 90 days
  • Has congenital heart disease with significant hemodynamic shunting
  • Has chemotherapy-induced heart failure
  • Has reversible cardiomyopathy
  • Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
  • Has diagnosed unstable angina pectoris
  • Has unstable coronary artery disease
  • Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
  • Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
  • Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
  • Has an existing neurostimulator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment

Control

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.

Secondary Outcome Measures

Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months

Full Information

First Posted
April 16, 2010
Last Updated
October 1, 2015
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01112579
Brief Title
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Acronym
DEFEAT-HF
Official Title
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Medtronic PrimeADVANCED Neurostimulator
Intervention Description
Heart failure therapy
Intervention Type
Device
Intervention Name(s)
Medtronic PrimeADVANCED Neurostimulator
Other Intervention Name(s)
Medical management
Intervention Description
Medical management
Primary Outcome Measure Information:
Title
Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
Time Frame
Baseline and 6 Months
Title
Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
Time Frame
Baseline and 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Left Ventricular Ejection Fraction (LVEF) of 35 percent or less New York Heart Association (NYHA) functional Class III at time of screening QRS duration less than 120 milliseconds (ms) Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months Receiving stable optimal medical therapy for heart failure prior to enrollment Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL) 18 years of age or older Willing and able to comply with study procedures Expected lifespan greater than 12 months beyond study enrollment as assessed by physician Exclusion Criteria: Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician Polyneuropathy Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy Unable to perform an exercise capacity test Pregnant or planning to become pregnant during this study Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days Had a heart transplant Has complete heart block Had Acute Coronary Syndrome within the past 90 days Has congenital heart disease with significant hemodynamic shunting Has chemotherapy-induced heart failure Has reversible cardiomyopathy Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area) Has diagnosed unstable angina pectoris Has unstable coronary artery disease Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater Has an existing neurostimulator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas P Zipes, M.D.
Organizational Affiliation
Krannert Institute of Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heinz Theres, M.D.
Organizational Affiliation
Charite Universitatsmedizin Berlin - Campus Charite Mitte
Official's Role
Principal Investigator
Facility Information:
City
Miami
State/Province
Florida
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Allentown
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Victoria
State/Province
British Columbia
Country
Canada
City
Prague
Country
Czech Republic
City
Berlin
Country
Germany
City
Herne
Country
Germany
City
Rome
Country
Italy
City
Groningen
Country
Netherlands
City
Maastricht
Country
Netherlands
City
Zwolle
Country
Netherlands
City
Cape Town
Country
South Africa
City
Johannesburg
Country
South Africa
City
Gothenburg
Country
Sweden
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26682789
Citation
Zipes DP, Neuzil P, Theres H, Caraway D, Mann DL, Mannheimer C, Van Buren P, Linde C, Linderoth B, Kueffer F, Sarazin SA, DeJongste MJL; DEFEAT-HF Trial Investigators. Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Systolic Heart Failure: The DEFEAT-HF Study. JACC Heart Fail. 2016 Feb;4(2):129-136. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9. Erratum In: JACC Heart Fail. 2018 Jun;6(6):542.
Results Reference
derived

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

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