Trial Outcomes & Findings for Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure (NCT NCT01112579)
NCT ID: NCT01112579
Last Updated: 2015-10-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2015-10-29
Participant Flow
Participant milestones
| Measure |
Treatment
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
24
|
|
Overall Study
COMPLETED
|
41
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Treatment
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
|---|---|---|
|
Overall Study
Missed Visit
|
1
|
1
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Baseline characteristics by cohort
| Measure |
Treatment
n=42 Participants
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
n=24 Participants
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 11 • n=99 Participants
|
66 years
STANDARD_DEVIATION 11 • n=107 Participants
|
61 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
3 Randomized participants
n=99 Participants
|
0 Randomized participants
n=107 Participants
|
3 Randomized participants
n=206 Participants
|
|
Region of Enrollment
Czech Republic
|
12 Randomized participants
n=99 Participants
|
10 Randomized participants
n=107 Participants
|
22 Randomized participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
9 Randomized participants
n=99 Participants
|
5 Randomized participants
n=107 Participants
|
14 Randomized participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
4 Randomized participants
n=99 Participants
|
5 Randomized participants
n=107 Participants
|
9 Randomized participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 Randomized participants
n=99 Participants
|
3 Randomized participants
n=107 Participants
|
12 Randomized participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
3 Randomized participants
n=99 Participants
|
0 Randomized participants
n=107 Participants
|
3 Randomized participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
1 Randomized participants
n=99 Participants
|
1 Randomized participants
n=107 Participants
|
2 Randomized participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
1 Randomized participants
n=99 Participants
|
0 Randomized participants
n=107 Participants
|
1 Randomized participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Treatment
n=40 Participants
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
n=20 Participants
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
|---|---|---|
|
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.
|
2.8 mL/m2
Standard Deviation 16.0
|
-3.6 mL/m2
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsOutcome measures
| Measure |
Treatment
n=34 Participants
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
n=21 Participants
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
|---|---|---|
|
Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
|
-32.4 pg/mL
Standard Deviation 994.0
|
73.8 pg/mL
Standard Deviation 1468.0
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsOutcome measures
| Measure |
Treatment
n=28 Participants
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
n=13 Participants
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
|---|---|---|
|
Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
|
0.6 mL/kg/min
Standard Deviation 4.1
|
-0.2 mL/kg/min
Standard Deviation 3.3
|
Adverse Events
Treatment
Serious events: 30 serious events
Other events: 19 other events
Deaths: 0 deaths
Control
Serious events: 16 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=42 participants at risk
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
n=24 participants at risk
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Atrial Fibrillation
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Cardiac Failure Acute
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Cardiac Perforation
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/42
|
8.3%
2/24 • Number of events 2
|
|
Cardiac disorders
Decompensated Heart Failure
|
38.1%
16/42 • Number of events 33
|
29.2%
7/24 • Number of events 15
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
Ventricular Arrhythmia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Ventricular Fibrillation
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Ventricular Tachycardia
|
2.4%
1/42 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Arterial Restenosis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Chest Pain
|
4.8%
2/42 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Death
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Device Extrusion
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Device Inappropriate Shock Delivery
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Device Lead Damage
|
2.4%
1/42 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Lead Dislodgement
|
7.1%
3/42 • Number of events 3
|
0.00%
0/24
|
|
General disorders
Sudden Cardiac Death
|
4.8%
2/42 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Sudden Death
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Hepatobiliary disorders
Ischaemic Hepatitis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Bronchopneumonia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/42
|
4.2%
1/24 • Number of events 3
|
|
Infections and infestations
Endocarditis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Implant Site Infection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Pericarditis Infective
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
9.5%
4/42 • Number of events 6
|
12.5%
3/24 • Number of events 3
|
|
Infections and infestations
Pyleonephritis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Respiratory Tract Infection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Septic Shock
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Investigations
International Normalised Ratio Increased
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/42
|
4.2%
1/24 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Neoplasm
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid Cancer Metastatic
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Loss of Consiousness
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Presyncope
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Sciatica
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Syncope
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Renal and urinary disorders
Renal Failure Chronic
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Endometrial Atrophy
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Dry Gangrene
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Vascular disorders
Aortic Dissection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Vascular disorders
Circulatory Collapse
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
|
Vascular disorders
Haematoma
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Vascular disorders
Hypotension
|
4.8%
2/42 • Number of events 2
|
0.00%
0/24
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/42
|
4.2%
1/24 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/24
|
Other adverse events
| Measure |
Treatment
n=42 participants at risk
Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
|
Control
n=24 participants at risk
Medtronic PrimeADVANCED Neurostimulator: Medical management
|
|---|---|---|
|
Cardiac disorders
Decompensated Heart Failure
|
19.0%
8/42 • Number of events 12
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
3/42 • Number of events 3
|
0.00%
0/24
|
|
General disorders
Adverse Drug Reaction
|
4.8%
2/42 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Device Stimulation Issue
|
11.9%
5/42 • Number of events 6
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Fatigue
|
0.00%
0/42
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
7.1%
3/42 • Number of events 3
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.1%
3/42 • Number of events 3
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/42
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/42
|
8.3%
2/24 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
4/42 • Number of events 4
|
12.5%
3/24 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.00%
0/42
|
8.3%
2/24 • Number of events 2
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/42
|
8.3%
2/24 • Number of events 2
|
Additional Information
DEFEAT-HF Clinical Team
Medtronic Cardiac Rhythm and Heart Failure
Phone: 1-800-328-2518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place