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

NCT01112579 | Completed Phase 2 Results DMC

• 1 other identifier: DEFEAT-HF
• Study Type: interventional
• Target: 81
• Locations: 8 countries
• Sites: 19

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (2)

• Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months

  Baseline and 6 Months

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

  Baseline and 6 Months

Study Arms (2)

Treatment

EXPERIMENTAL

Device: Medtronic PrimeADVANCED Neurostimulator

Control

OTHER

Device: Medtronic PrimeADVANCED Neurostimulator

Interventions

Medtronic PrimeADVANCED Neurostimulator DEVICE

Heart failure therapy

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (19)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Allentown, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Victoria, British Columbia, Canada

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Herne, Germany

Location

Unknown Facility

Rome, Italy

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Maastricht, Netherlands

Location

Unknown Facility

Zwolle, Netherlands

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 26682789 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: DEFEAT-HF Clinical Team
• Organization: Medtronic Cardiac Rhythm and Heart Failure

MedtronicCRMtrials@medtronic.com

1-800-328-2518

Study Officials

• Douglas P Zipes, M.D.

  Krannert Institute of Cardiology

  PRINCIPAL INVESTIGATOR

• Heinz Theres, M.D.

  Charite Universitatsmedizin Berlin - Campus Charite Mitte

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 28, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2015
• Last Updated: October 29, 2015
• Results First Posted: October 29, 2015

Record last verified: 2015-10

Locations

ZA (2); CA (2); NL (3); CZ (1); DE (2); IT (1); US (6); SE (2)