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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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