Trial Outcomes & Findings for TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD (NCT NCT01043705)

NCT ID: NCT01043705

Last Updated: 2015-12-24

Results Overview

CIED Major Infections

• Recruitment status: COMPLETED
• Target enrollment: 1262 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2015-12-24

Participant Flow

First Patient Enrolled = 1 January 2010; Last Patient Enrolled = 7 May 2013

CRT and ICD Implant patients with TYRX Implant; Full analysis cohort = 1,129 patients. 670 patient CRT + TYRX cohort is subset. 459 patient ICD + TYRX is subset. 578 CRT+ TYRX patient cohort is subset matched to 578 patient CRT/no TYRX retrospective patient arm.

Participant milestones

Measure	ICD With TYRX Implant All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant	CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match	CRT With no TYRX Retrospective Case Control Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
Overall Study STARTED	459	578	578
Overall Study COMPLETED	352	447	498
Overall Study NOT COMPLETED	107	131	80

Reasons for withdrawal

Measure	ICD With TYRX Implant All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant	CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match	CRT With no TYRX Retrospective Case Control Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
Overall Study Death	28	60	26
Overall Study Lost to Follow-up	27	12	0
Overall Study Multiple Reasons	4	7	0
Overall Study Protocol Violation	2	1	0
Overall Study Withdrawal by Subject	8	6	0
Overall Study Site Closure	8	0	0
Overall Study Subsequent Procedure	9	24	29
Overall Study Adverse Event	0	2	0
Overall Study Screen Fail	21	0	0
Overall Study Other	0	19	25

Baseline Characteristics

TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD

Baseline characteristics by cohort

Measure	CIED Replacement With ICD and TYRX n=459 Participants (Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.	CIED Replacement With CRT and no TYRX n=578 Participants (Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.	CIED Replacement With CRT and TYRX Vs. Case Match Arm n=578 Participants Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients	Total n=1615 Participants Total of all reporting groups
Age, Continuous	70 Years STANDARD_DEVIATION 12.01 • n=5 Participants	73 Years STANDARD_DEVIATION 10.94 • n=7 Participants	73 Years STANDARD_DEVIATION 10.70 • n=5 Participants	72 Years STANDARD_DEVIATION 11.45 • n=4 Participants
Sex: Female, Male Female	339 Participants n=5 Participants	434 Participants n=7 Participants	444 Participants n=5 Participants	1217 Participants n=4 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	144 Participants n=7 Participants	134 Participants n=5 Participants	398 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Evaluable patients that have valid entry criteria

CIED Major Infections

Outcome measures

Measure	CIED Replacement With CRT and TYRX n=670 Participants (Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.	CIED Replacement With CRT and no TYRX n=578 Participants (Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.	CIED Replacement With CRT and TYRX vs. Case Match Arm n=578 Participants CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
Major CIED Infection	0.6 percentage of Participants Interval 0.0 to 1.4	1.0 percentage of Participants Interval 0.0 to 2.0	0.7 percentage of Participants Interval 0.0 to 1.6

PRIMARY outcome

Timeframe: 12 months

Population: TYRX implants vs. published comparator are "prospective arm" patients. Non-TYRX CIED retrospective arm vs. TYRX CIED replacements are nested, case-control cohort.

All mechanical Complications related to CIED Implant

Outcome measures

Measure	CIED Replacement With CRT and TYRX n=459 Participants (Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.	CIED Replacement With CRT and no TYRX n=578 Participants (Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.	CIED Replacement With CRT and TYRX vs. Case Match Arm n=578 Participants CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
CIED Mechanical Complication	3.1 percentage of Participants Interval 1.7 to 5.1	5.5 percentage of Participants Interval 3.8 to 7.7	5.4 percentage of Participants Interval 3.7 to 7.5

Adverse Events

CIED Replacement With CRT and TYRX

Serious events: 96 serious events

Other events: 0 other events

Deaths: 0 deaths

CIED Replacement With ICD and TYRX

Serious events: 46 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	CIED Replacement With CRT and TYRX n=578 participants at risk (Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.	CIED Replacement With ICD and TYRX n=459 participants at risk (Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
Surgical and medical procedures Emergency Care	0.87% 5/578 • Number of events 5 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Endotracheal Intubation	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Haemodialysis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Hospice Care	0.69% 4/578 • Number of events 4 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Hospitalisation	4.7% 27/578 • Number of events 27 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	2.2% 10/459 • Number of events 10 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Blood and lymphatic system disorders Anaemia	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Blood and lymphatic system disorders Leukocytosis	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Acute Myocardial Infarction	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Aortic Valve Stenosis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Atrial Fibrillation	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Atrial Thrombosis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiac Amyloidosis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiac Arrest	0.87% 5/578 • Number of events 5 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.44% 2/459 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiac disorder	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiac Failure	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiac Failure Acute	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiac Failure Congestive	3.1% 18/578 • Number of events 18 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	1.3% 6/459 • Number of events 6 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardio-respiratory failure	0.69% 4/578 • Number of events 4 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiogenic Shock	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiomyopathy	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Cardiopulmonary Failure	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Coronary Artery Disease	0.52% 3/578 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Ischemic Cardiomyopathy	0.52% 3/578 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Low Cardiac Output Syndrome	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Mitral Valve Incompetence	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Myocardial Infarction	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Palpitations	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Implantable Defibrillator Insertion	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Restrictive Cardiomyopathy	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Tricuspid Valve Incompetence	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Cardiac disorders Ventricular Tachycardia	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.44% 2/459 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Endocrine disorders Hypothyroidism	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Gastrointestinal disorders Gastrointestinal Heamorrhage	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Gastrointestinal disorders Rectal Haemorrhage	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Adverse Drug Reaction	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Asthenia	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Brain Death	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Chest Pain	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Chills	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Complication of Device Removal	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Condition Aggravated	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Death	7.8% 45/578 • Number of events 45 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	5.2% 24/459 • Number of events 24 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Component Issue	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device dislocation	0.69% 4/578 • Number of events 4 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Electrical Finding	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Failure	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Lead Damage	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Lead Issue	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Malfunction	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Pacing Issue	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Device Stimulation Issue	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Feeling Hot	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders General Physical Health Deterioration	0.69% 4/578 • Number of events 4 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Impaired Healing	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Implant Site Discharge	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Implant Site Haematoma	1.0% 6/578 • Number of events 6 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Implant Site Haemorrhage	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Implant Site Pain	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Medical Device Site Reaction	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Multi-Organ Failure	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Multimorbidity	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Oedema Peripheral	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Pyrexia	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
General disorders Treatment Failure	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Cardiac Valve Vegetation	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Device Related Infection	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Endocarditis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Implant Site Cellulitis	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Implant Site Infection	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.65% 3/459 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Infected Skin Ulcer	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Infection	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Klebsiella Sepsis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Pneumonia	1.2% 7/578 • Number of events 7 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.44% 2/459 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Pneumonia Staphylococcal	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Sepsis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.44% 2/459 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Septic Shock	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Staphylococcal Bacteraemia	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Streptococcal Sepsis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Urinary Tract Infection	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Infections and infestations Urosepsis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Eschar	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Fall	0.52% 3/578 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Fibula Fracture	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Incision Site Haematoma	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Post Procedural Discharge	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Seroma	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Tibia Fracture	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Injury, poisoning and procedural complications Wound Dehiscence	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Investigations Blood Creatinine Increased	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Investigations Blood Culture Positive	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Investigations Blood Urea Increased	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Investigations Blood Urea Nitrogen/Creatinine Ratio Increased	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Investigations International Normalised Ratio Increased	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Investigations Troponin Increased	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Metabolism and nutrition disorders Dehydration	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Metabolism and nutrition disorders Diabetes Mellitus	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Metabolism and nutrition disorders Failure to Thrive	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Metabolism and nutrition disorders Hyponatraemia	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Metabolism and nutrition disorders Hypovolaemia	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Musculoskeletal and connective tissue disorders Arthralgia	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgin's Disease	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Recurrent	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Nervous system disorders Convulsion	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Nervous system disorders Dementia	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Nervous system disorders Ischaemic Stroke	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Nervous system disorders Lethargy	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Nervous system disorders Loss of Consciousness	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Nervous system disorders Presyncope	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Nervous system disorders Syncope	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Psychiatric disorders Anxiety	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Psychiatric disorders Confusional State	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Renal and urinary disorders Renal Failure	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.44% 2/459 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Renal and urinary disorders Renal Failure Acute	0.69% 4/578 • Number of events 4 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Renal and urinary disorders Renal Failure Chronic	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Renal and urinary disorders Renal Mass	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Cough	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 9/578 • Number of events 9 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.87% 4/459 • Number of events 4 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Lung Consolidation	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Long Disorder	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.52% 3/578 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Skin and subcutaneous tissue disorders Rash	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Skin and subcutaneous tissue disorders Skin Erosion	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Aortic Valve Replacement	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Cardiac Pacemaker Removal	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Cardiac Pacemaker Replacement	0.52% 3/578 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Cardio Pacemaker Revision	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Cardioversion	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Chest Tube Insertion	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Drain Placement	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Incisional Drainage	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Mechanical Ventilation	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Medical Device Change	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Medical Device Removal	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Packed Red Blood Cell Transfusion	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Palliative Care	0.35% 2/578 • Number of events 2 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.65% 3/459 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Rehabilitation Therapy	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Tracheostomy	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Ventricular Assist Device Insertion	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Withdrawal of Life Support	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Surgical and medical procedures Wound Drainage	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Vascular disorders Distributive Shock	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Vascular disorders Haematoma	0.00% 0/578 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.22% 1/459 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Vascular disorders Hypotension	0.52% 3/578 • Number of events 3 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.
Vascular disorders Peripheral Arterial Occlusive Disease	0.17% 1/578 • Number of events 1 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.	0.00% 0/459 • During 12 month follow up period Note that non-serious adverse events were not collected or assessed as part of this study. Adverse events coded as "death" do not have further description.

Other adverse events

Adverse event data not reported

Additional Information

Lynn Landborg, Clinical Research Manager

Medtronic plc

Phone: 763 526 2877

Email: lynn.landborg@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place