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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01112579
First received: April 16, 2010
Last updated: March 26, 2014
Last verified: March 2014
  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 Blind (Subject)
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 Disease Management:

Primary Outcome Measures:
  • Change in left ventricular volumes as measured by cardiac echo [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood chemistry change as measured by proBNP [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • Exercise capacity change as measured by peak oxygen uptake [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: April 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: Medtronic PrimeADVANCED Neurostimulator
Heart failure therapy
Other Name: Medtronic PrimeADVANCED Neurostimulator
Control Device: Medtronic PrimeADVANCED Neurostimulator
Medical management
Other Name: Medical management

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Disease Management
Investigators
Principal Investigator: Douglas P Zipes, M.D. Krannert Institute of Cardiology
Principal Investigator: Heinz Theres, MD Charite Universitatsmedizin Berlin - Campus Charite Mitte
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01112579     History of Changes
Other Study ID Numbers: Defeat-HF
Study First Received: April 16, 2010
Last Updated: March 26, 2014
Health Authority: Sweden: Medical Products Agency
Sweden: Institutional Review Board
Italy: Ethics Committee
Italy: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014