Trial Outcomes & Findings for Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) (NCT NCT01385176)

Last Updated: 2026-02-12

Results Overview

Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm. The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

118 participants

Primary outcome timeframe

LVESD at Baseline and at 6-months post Baseline

Results posted on

2026-02-12

Participant Flow

Enrollment Start: 21-Sep-2011. First implant: 28-Sep-2011.Last Implant: 20-June-2013. 118 patients enrolled, 96 were found to be eligible and were implanted across 24 centres (7 sites with 5-10 implants, 1 site with 13 implants). 95 patients were randomized.

22 patients were excluded after enrollment. 18 patients did not meet the inclusion criteria. 4 patients decided to withdraw their consent. 96 patients were finally implanted with the investigational device. One patient died after implant and before randomization. Randomization was done only after the investigational device implant had occurred.

Participant milestones

Participant milestones
Measure	Therapy Vagus nerve stimulation system was implanted in the Therapy group as well as in the control group. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON, Therapy) or control (VNS OFF, Control) for a 6-month period. The experimental arm was receiving vagus nerve stimulation soon after implant. Patients randomized to control arm were not receiving right vagal nerve stimulation for the first 6-months post-implant, after which they did also receive therapy.	Control Control group was implanted with study system like the experimental arm, but did receive no therapy until 6-month cross-over. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months after implant: Patients randomized to control arm did not receive right vagal nerve stimulation for the first 6-months post-implant, after which they will also receive therapy.
Randomization Phase STARTED	63	32
Randomization Phase COMPLETED	62	30
Randomization Phase NOT COMPLETED	1	2
6-18 Month All VNS Active STARTED	62	30
6-18 Month All VNS Active COMPLETED	58	27
6-18 Month All VNS Active NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapy Vagus nerve stimulation system was implanted in the Therapy group as well as in the control group. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON, Therapy) or control (VNS OFF, Control) for a 6-month period. The experimental arm was receiving vagus nerve stimulation soon after implant. Patients randomized to control arm were not receiving right vagal nerve stimulation for the first 6-months post-implant, after which they did also receive therapy.	Control Control group was implanted with study system like the experimental arm, but did receive no therapy until 6-month cross-over. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months after implant: Patients randomized to control arm did not receive right vagal nerve stimulation for the first 6-months post-implant, after which they will also receive therapy.
Randomization Phase Death	1	2
6-18 Month All VNS Active Death	1	2
6-18 Month All VNS Active Physician Decision	0	1
6-18 Month All VNS Active Withdrawal by Subject	2	0
6-18 Month All VNS Active Heart Transplant	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapy n=63 Participants Therapy group was implanted with study system like the control arm, but did receive therapy soon after implant	Control n=32 Participants Control group was implanted with study system like the experimental arm, but will receive no therapy until 6-month cross-over. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months: Patients randomized to therapy arm with receive right vagal nerve stimulation. Patients randomized to control arm will not receive right vagal nerve stimulation for the first 6-months post-implant, after which they will also receive therapy.	Total n=95 Participants Total of all reporting groups
Region of Enrollment Netherlands	13 participants n=63 Participants	6 participants n=32 Participants	19 participants n=95 Participants
Region of Enrollment Czech Republic	6 participants n=63 Participants	4 participants n=32 Participants	10 participants n=95 Participants
Age, Continuous	59.8 years STANDARD_DEVIATION 12.2 • n=63 Participants	59.3 years STANDARD_DEVIATION 10.1 • n=32 Participants	59.5 years STANDARD_DEVIATION 11.1 • n=95 Participants
Sex: Female, Male Female	7 Participants n=63 Participants	6 Participants n=32 Participants	13 Participants n=95 Participants
Sex: Female, Male Male	56 Participants n=63 Participants	26 Participants n=32 Participants	82 Participants n=95 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	1 participants n=63 Participants	1 participants n=32 Participants	2 participants n=95 Participants
Region of Enrollment United Kingdom	12 participants n=63 Participants	4 participants n=32 Participants	16 participants n=95 Participants
Region of Enrollment Italy	5 participants n=63 Participants	5 participants n=32 Participants	10 participants n=95 Participants
Region of Enrollment France	4 participants n=63 Participants	3 participants n=32 Participants	7 participants n=95 Participants
Region of Enrollment Germany	12 participants n=63 Participants	4 participants n=32 Participants	16 participants n=95 Participants
Region of Enrollment Spain	10 participants n=63 Participants	5 participants n=32 Participants	15 participants n=95 Participants
Body mass index	28.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=63 Participants	31.2 kg/m^2 STANDARD_DEVIATION 5.1 • n=32 Participants	29.9 kg/m^2 STANDARD_DEVIATION 5.5 • n=95 Participants
Loop diuretics	54 Participants n=63 Participants	32 Participants n=32 Participants	86 Participants n=95 Participants
Statin	50 Participants n=63 Participants	19 Participants n=32 Participants	69 Participants n=95 Participants

PRIMARY outcome

Timeframe: LVESD at Baseline and at 6-months post Baseline

Population: The sign (- ) indicates a reduction in the LVESD. Participants without paired endpoint data did not contribute to the analysis.

Outcome measures

Outcome measures
Measure	Therapy n=59 Participants Vagus nerve stimulation system was implanted. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The experimental arm was receiving vagus nerve stimulation starting at Baseline.	Control n=28 Participants Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they will also receive vagus nerve stimulation. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months.
Change in Left Ventricular End-systolic Dimension (LVESD)	-0.04 cm Standard Deviation 0.25	-0.08 cm Standard Deviation 0.32

PRIMARY outcome

Timeframe: 18-months

Population: Therapy group received VNS from implant to 18 months. Control group received VNS from 6 months to 18 months. These follow-up periods contributed to the endpoint analysis. Both groups were combined for mortality endpoint analysis. Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.

As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.

Outcome measures

Outcome measures
Measure	Therapy n=92 Participants Vagus nerve stimulation system was implanted. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The experimental arm was receiving vagus nerve stimulation starting at Baseline.	Control Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they will also receive vagus nerve stimulation. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months.
Percentage of Surviving Participants	95 Percentage of participants surving Interval 91.0 to 99.0	—

SECONDARY outcome

Timeframe: LVEF at Baseline and at 6-months after Baseline

Population: LVEF echocardiographic measurements were made at Baseline and at 6 months after Baseline. Participants without paired endpoint data did not contribute to the analysis.

LVEF, left ventricular ejection fraction.

Outcome measures

Outcome measures
Measure	Therapy n=59 Participants Vagus nerve stimulation system was implanted. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The experimental arm was receiving vagus nerve stimulation starting at Baseline.	Control n=27 Participants Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they will also receive vagus nerve stimulation. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months.
LVEF, Left Ventricular Ejection Fraction Baseline	30.5 % of blood ejected from ventricle Standard Deviation 6.0	30.8 % of blood ejected from ventricle Standard Deviation 4.2
LVEF, Left Ventricular Ejection Fraction 6 months after Baseline	32.7 % of blood ejected from ventricle Standard Deviation 6.4	32.1 % of blood ejected from ventricle Standard Deviation 5.6

SECONDARY outcome

Timeframe: Measurements at Baseline and at 6-months after Baseline

Population: Participants without paired endpoint data did not contribute to the analysis.

Assessment of functional capacity (e.g., peak VO2) as measures related to patient heart failure status.

Outcome measures

Outcome measures
Measure	Therapy n=56 Participants Vagus nerve stimulation system was implanted. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The experimental arm was receiving vagus nerve stimulation starting at Baseline.	Control n=27 Participants Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they will also receive vagus nerve stimulation. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months.
Exercise Capacity, Peak VO2 Baseline	15.6 ml/kg/min Standard Deviation 3.9	15.2 ml/kg/min Standard Deviation 3.3
Exercise Capacity, Peak VO2 6 months after Baseline	15.8 ml/kg/min Standard Deviation 4.4	14.7 ml/kg/min Standard Deviation 3.6

SECONDARY outcome

Timeframe: At Baseline and at 6-months after Baseline

Population: Measurements of LVESV, left ventricular end systolic volume at Baseline and at 6-months after Baseline. Participants without paired endpoint data did not contribute to the analysis.

Measurements of LVESV, left ventricular end systolic volume at Baseline and 6 months after Baseline in the Control Arm and in the Therapy Arm

Outcome measures

Outcome measures
Measure	Therapy n=59 Participants Vagus nerve stimulation system was implanted. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The experimental arm was receiving vagus nerve stimulation starting at Baseline.	Control n=27 Participants Control group was implanted with study system like the experimental arm, but did not receive vagus nerve stimulation for the first 6 months after Baseline, after which they will also receive vagus nerve stimulation. Vagal Nerve Stimulation System was implanted but inactive for the first 6 months.
LVESV, Left Ventricular End Systolic Volume Baseline	154.7 ml Standard Deviation 58.5	164.0 ml Standard Deviation 39.2
LVESV, Left Ventricular End Systolic Volume 6 months after Baseline	142.5 ml Standard Deviation 57.1	152.1 ml Standard Deviation 43.8

Adverse Events

Therapy

Serious events: 21 serious events

Other events: 32 other events

Deaths: 1 deaths

Control

Serious events: 18 serious events

Other events: 15 other events

Deaths: 2 deaths

All Patients - 6 to 18 Months

Serious events: 44 serious events

Other events: 66 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Therapy n=63 participants at risk Vagus nerve stimulation system was implanted in the Therapy group as well as in the control group. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON, Therapy) or control (VNS OFF, Control) for a 6-month period. Patients randomized to therapy arm were receiving right vagal nerve stimulation shortly after implant.	Control n=32 participants at risk Control group was implanted with study system like the experimental arm, but did receive no therapy until 6-month cross-over. Patients randomized to control arm did not receive right vagal nerve stimulation for the first 6-months post-implant, after which they did also receive therapy.	All Patients - 6 to 18 Months n=92 participants at risk All patients were receiving vagus nerve stimulation after the initial 6 months of randomization. Three of the initially 95 randomized patients died before the end of the randomization phase, reducing the number to 92 patients. Note, 5 patients did not complete the Randomization phase with the 6 month follow up visit, but were still participating in the study at the time the Randomization Phase Analysis was done. These 5 patients were at risk to have an AE and were included in this analysis set (N=92)
Cardiac disorders Death, anticipated	1.6% 1/63 • Number of events 1 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	6.2% 2/32 • Number of events 2 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	3.3% 3/92 • Number of events 3 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders HF hospitalization, anticipated	11.1% 7/63 • Number of events 10 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	15.6% 5/32 • Number of events 9 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	19.6% 18/92 • Number of events 32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders Cardiovascular - Non Heart Failure, anticipated	11.1% 7/63 • Number of events 9 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	15.6% 5/32 • Number of events 7 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	17.4% 16/92 • Number of events 26 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Respiratory, thoracic and mediastinal disorders Pulmonary Serious Adverse Events, anticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	9.4% 3/32 • Number of events 3 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	5.4% 5/92 • Number of events 6 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Renal and urinary disorders Genitourinary, anticipated	1.6% 1/63 • Number of events 1 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	6.2% 2/32 • Number of events 2 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	1.1% 1/92 • Number of events 2 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
General disorders Other Non Cardiocascular, anticipated	11.1% 7/63 • Number of events 7 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	21.9% 7/32 • Number of events 7 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	23.9% 22/92 • Number of events 33 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Product Issues Investigational device system related, anticipated	14.3% 9/63 • Number of events 9 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	12.5% 4/32 • Number of events 4 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	2.2% 2/92 • Number of events 2 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders Heart Failure Hospitalizations, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders Cardiovascular - Non Heart Failure, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Respiratory, thoracic and mediastinal disorders Pulmonary Serious Adverse Events, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Renal and urinary disorders Genitourinary, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Product Issues Investigational device system related, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	1.1% 1/92 • Number of events 1 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
General disorders Other Non Cardiocascular, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders Death, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.

Other adverse events

Other adverse events
Measure	Therapy n=63 participants at risk Vagus nerve stimulation system was implanted in the Therapy group as well as in the control group. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON, Therapy) or control (VNS OFF, Control) for a 6-month period. Patients randomized to therapy arm were receiving right vagal nerve stimulation shortly after implant.	Control n=32 participants at risk Control group was implanted with study system like the experimental arm, but did receive no therapy until 6-month cross-over. Patients randomized to control arm did not receive right vagal nerve stimulation for the first 6-months post-implant, after which they did also receive therapy.	All Patients - 6 to 18 Months n=92 participants at risk All patients were receiving vagus nerve stimulation after the initial 6 months of randomization. Three of the initially 95 randomized patients died before the end of the randomization phase, reducing the number to 92 patients. Note, 5 patients did not complete the Randomization phase with the 6 month follow up visit, but were still participating in the study at the time the Randomization Phase Analysis was done. These 5 patients were at risk to have an AE and were included in this analysis set (N=92)
Cardiac disorders Cardiovascular HF related, anticipated	23.8% 15/63 • Number of events 20 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	21.9% 7/32 • Number of events 9 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	22.8% 21/92 • Number of events 31 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders Cardiovascular - not HF related, anticipated	33.3% 21/63 • Number of events 31 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	40.6% 13/32 • Number of events 18 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	30.4% 28/92 • Number of events 40 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Investigations Investigational System-Related anticipated	50.8% 32/63 • Number of events 55 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	34.4% 11/32 • Number of events 18 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	27.2% 25/92 • Number of events 34 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Respiratory, thoracic and mediastinal disorders Pulmonary non serious adverse events, anticipated	3.2% 2/63 • Number of events 2 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	6.2% 2/32 • Number of events 2 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	8.7% 8/92 • Number of events 8 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Renal and urinary disorders Genitourinary, anticipated	1.6% 1/63 • Number of events 1 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	3.1% 1/32 • Number of events 2 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	3.3% 3/92 • Number of events 3 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
General disorders Other Non-cardiovascular, anticipated	30.2% 19/63 • Number of events 28 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	40.6% 13/32 • Number of events 20 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	37.0% 34/92 • Number of events 56 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders Cardiovascular HF related, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Cardiac disorders Cardiovascular - not HF related, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Respiratory, thoracic and mediastinal disorders Pulmonary non serious adverse events, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Renal and urinary disorders Genitourinary, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
General disorders Other Non-cardiovascular, unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.
Product Issues Investigational System-Related unanticipated	0.00% 0/63 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/32 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.	0.00% 0/92 • Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period. Adverse Event Definitions as per ISO 14155 were utilized. The study had only patients from European countries enrolled.

Additional Information

Principal Investigator of the Study, Prof. Faiez Zannad

Institut Lorrain du Coeur et des Vaisseaux, CHU de Nancy, France

Phone: +33 3 83 15 73 22

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place