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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01112579
First Posted: April 28, 2010
Last Update Posted: October 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
  Purpose
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

Condition Intervention Phase
Heart Failure Device: Medtronic PrimeADVANCED Neurostimulator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

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. [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures:
  • Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months [ Time Frame: 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 ]

Enrollment: 81
Study Start Date: April 2010
Study Completion Date: April 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: Medtronic PrimeADVANCED Neurostimulator
Heart failure therapy
Control Device: Medtronic PrimeADVANCED Neurostimulator
Medical management
Other Name: Medical management

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112579


Locations
United States, Florida
Miami, Florida, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Vermont
Burlington, Vermont, United States
United States, Washington
Spokane, Washington, United States
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
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: Douglas P Zipes, M.D. Krannert Institute of Cardiology
Principal Investigator: Heinz Theres, M.D. Charite Universitatsmedizin Berlin - Campus Charite Mitte
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01112579     History of Changes
Other Study ID Numbers: DEFEAT-HF
First Submitted: April 16, 2010
First Posted: April 28, 2010
Results First Submitted: October 1, 2015
Results First Posted: October 29, 2015
Last Update Posted: October 29, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases