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

October 1, 2015 updated by: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
  • Czech Republic
      • Prague, Czech Republic
  • Germany
      • Berlin, Germany
      • Herne, Germany
  • Italy
      • Rome, Italy
  • Netherlands
      • Groningen, Netherlands
      • Maastricht, Netherlands
      • Zwolle, Netherlands
  • South Africa
      • Cape Town, South Africa
      • Johannesburg, South Africa
  • Sweden
      • Gothenburg, Sweden
      • Stockholm, Sweden
  • United States
    • Florida
      • Miami, Florida, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Vermont
      • Burlington, Vermont, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Device: Medtronic PrimeADVANCED Neurostimulator
Heart failure therapy
Device: Medtronic PrimeADVANCED Neurostimulator
Medical management
Other Names:
  • Medical management
Other: Control
Device: Medtronic PrimeADVANCED Neurostimulator
Heart failure therapy
Device: Medtronic PrimeADVANCED Neurostimulator
Medical management
Other Names:
  • Medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
Time Frame: Baseline and 6 Months
Baseline and 6 Months
Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
Time Frame: Baseline and 6 Months
Baseline and 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: Douglas P Zipes, M.D., Krannert Institute of Cardiology
  • Principal Investigator: Heinz Theres, M.D., Charité Universitätsmedizin Berlin - Campus Charité Mitte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEFEAT-HF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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