Determining the Feasibility of Spinal Cord Neuromodulatio... | NCT01112579

Status Module

Oversight Module

Label	Type	Description	Intervention Names
Treatment	Experimental		Device: Medtronic PrimeADVANCED Neurostimulator
Control	Other		Device: Medtronic PrimeADVANCED Neurostimulator

Name	Type	Description	Arm Group Labels	Other Names
Medtronic PrimeADVANCED Neurostimulator	Device	Heart failure therapy	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	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.		Baseline and 6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility 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

Name	Affiliation	Role
Douglas P Zipes, M.D.	Krannert Institute of Cardiology	Principal Investigator
Heinz Theres, M.D.	Charite Universitatsmedizin Berlin - Campus Charite Mitte	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26682789	Derived	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.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Treatment	Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
FG001	Control	Medtronic PrimeADVANCED Neurostimulator: Medical management

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Treatment	Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
BG001	Control	Medtronic PrimeADVANCED Neurostimulator: Medical management
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00042 BG00124 BG00266

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

Standard Deviation

mL/m2

Baseline and 6 months

ID	Title	Description
OG000	Treatment	Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
OG001	Control	Medtronic PrimeADVANCED Neurostimulator: Medical management

Units	Counts
Participants	OG00040 OG00120

Title

Denominators

Categories

Title	Measurements
	OG0002.8± 16.0 OG001-3.6± 14.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.3		Mean Difference (Final Values)	6.4			2-Sided	95	-2.0	14.9				No	Superiority or Other

Secondary

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

Posted

Mean

Standard Deviation

pg/mL

Baseline and 6 Months

ID	Title	Description
OG000	Treatment	Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
OG001	Control	Medtronic PrimeADVANCED Neurostimulator: Medical management

Units	Counts
Participants	OG00034

Secondary

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

Posted

Mean

Standard Deviation

mL/kg/min

Baseline and 6 Months

ID	Title	Description
OG000	Treatment	Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
OG001	Control	Medtronic PrimeADVANCED Neurostimulator: Medical management

Units	Counts
Participants	OG00028

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Atrial Fibrillation	Cardiac disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Atrial Tachycardia	Cardiac disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Bradycardia	Cardiac disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Cardiac Failure Acute	Cardiac disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Cardiac Failure Congestive	Cardiac disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Cardiac Perforation	Cardiac disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Cardiogenic Shock	Cardiac disorders	EG0000 events0 affected42 at risk EG0012 events2 affected24 at risk
Decompensated Heart Failure	Cardiac disorders	EG00033 events16 affected42 at risk EG00115 events7 affected24 at risk
Pericardial Effusion	Cardiac disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Ventricular Arrhythmia	Cardiac disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Ventricular Fibrillation	Cardiac disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Ventricular Tachycardia	Cardiac disorders	EG0001 events1 affected42 at risk EG0013 events3 affected24 at risk
Abdominal Wall Haematoma	Gastrointestinal disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Ascites	Gastrointestinal disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Gastritis	Gastrointestinal disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Pancreatic Cyst	Gastrointestinal disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Pancreatitis	Gastrointestinal disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Vomiting	Gastrointestinal disorders	EG0000 events0 affected42 at risk EG0012 events1 affected24 at risk
Adverse Drug Reaction	General disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Arterial Restenosis	General disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Chest Pain	General disorders	EG0002 events2 affected42 at risk EG0010 events0 affected24 at risk
Death	General disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Device Extrusion	General disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Device Inappropriate Shock Delivery	General disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Device Lead Damage	General disorders	EG0001 events1 affected42 at risk EG0011 events1 affected24 at risk
Lead Dislodgement	General disorders	EG0003 events3 affected42 at risk EG0010 events0 affected24 at risk
Sudden Cardiac Death	General disorders	EG0002 events2 affected42 at risk EG0010 events0 affected24 at risk
Sudden Death	General disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Ischaemic Hepatitis	Hepatobiliary disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Bronchopneumonia	Infections and infestations	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Clostridium Difficile Colitis	Infections and infestations	EG0000 events0 affected42 at risk EG0013 events1 affected24 at risk
Endocarditis	Infections and infestations	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Gastroenteritis	Infections and infestations	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Implant Site Infection	Infections and infestations	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Pericarditis Infective	Infections and infestations	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Pneumonia	Infections and infestations	EG0006 events4 affected42 at risk EG0013 events3 affected24 at risk
Pyleonephritis	Infections and infestations	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Respiratory Tract Infection	Infections and infestations	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Septic Shock	Infections and infestations	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Urinary Tract Infection	Infections and infestations	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Femur Fracture	Injury, poisoning and procedural complications	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
International Normalised Ratio Increased	Investigations	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Dehydration	Metabolism and nutrition disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Gout	Metabolism and nutrition disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Hypoglycaemia	Metabolism and nutrition disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0000 events0 affected42 at risk EG0012 events1 affected24 at risk
Bursitis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Gouty Arthritis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Gallbladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Rectosigmoid Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Cerebrovascular Accident	Nervous system disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Epilepsy	Nervous system disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Loss of Consiousness	Nervous system disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Presyncope	Nervous system disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Sciatica	Nervous system disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Syncope	Nervous system disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Renal Failure	Renal and urinary disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Renal Failure Acute	Renal and urinary disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Renal Failure Chronic	Renal and urinary disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Endometrial Atrophy	Reproductive system and breast disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Dry Gangrene	Skin and subcutaneous tissue disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Aortic Dissection	Vascular disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Circulatory Collapse	Vascular disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk
Haematoma	Vascular disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Hypotension	Vascular disorders	EG0002 events2 affected42 at risk EG0010 events0 affected24 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	EG0000 events0 affected42 at risk EG0011 events1 affected24 at risk
Thrombosis	Vascular disorders	EG0001 events1 affected42 at risk EG0010 events0 affected24 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Decompensated Heart Failure	Cardiac disorders	EG00012 events8 affected42 at risk EG0013 events3 affected24 at risk
Dyspepsia	Gastrointestinal disorders	EG0003 events3 affected42 at risk EG0010 events0 affected24 at risk
Adverse Drug Reaction	General disorders	EG0002 events2 affected42 at risk EG0012 events2 affected24 at risk
Device Stimulation Issue	General disorders	EG0006 events5 affected42 at risk EG0013 events3 affected24 at risk
Fatigue	General disorders	EG0000 events0 affected42 at risk EG0012 events2 affected24 at risk
Bronchitis	Infections and infestations	EG0003 events3 affected42 at risk EG0010 events0 affected24 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	EG0003 events3 affected42 at risk EG0010 events0 affected24 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG0000 events0 affected42 at risk EG0012 events2 affected24 at risk
Dizziness	Nervous system disorders	EG0000 events0 affected42 at risk EG0012 events2 affected24 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0004 events4 affected42 at risk EG0014 events3 affected24 at risk
Skin Reaction	Skin and subcutaneous tissue disorders	EG0000 events0 affected42 at risk EG0012 events2 affected24 at risk
Orthostatic Hypotension	Vascular disorders	EG0000 events0 affected42 at risk EG0012 events2 affected24 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Miami	Florida		United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment	Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy			30	42	19	42
EG001	Control	Medtronic PrimeADVANCED Neurostimulator: Medical management			16	24	12	24