Trial Outcomes & Findings for Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation (NCT NCT02064764)

NCT ID: NCT02064764

Last Updated: 2024-02-23

Results Overview

Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

102 participants

Primary outcome timeframe

Up to one or six months post procedure depending on the event

Results posted on

2024-02-23

Participant Flow

The first subject was enrolled on February 6, 2015 and the last subject was enrolled on September 9, 2020

28 subjects were exited prior to randomization for not meeting study eligibility criteria. Of the 74 randomized subjects, 3 in the PVI+RDN group were not treated and 1 in the Control group (PVI only) were not treated.

Participant milestones

Participant milestones
Measure	Cryoablation Only Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Overall Study STARTED	36	34
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System	Total n=70 Participants Total of all reporting groups
Age, Continuous	65.1 years STANDARD_DEVIATION 7.8 • n=93 Participants	65.8 years STANDARD_DEVIATION 7.8 • n=4 Participants	65.4 years STANDARD_DEVIATION 7.7 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	18 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	16 Participants n=4 Participants	39 Participants n=27 Participants
Race/Ethnicity, Customized Not reportable per local laws or regulations	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Subject/Physician Chose Not to Provide Information	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized White	27 Participants n=93 Participants	28 Participants n=4 Participants	55 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	28 participants n=93 Participants	24 participants n=4 Participants	52 participants n=27 Participants
Region of Enrollment Germany	8 participants n=93 Participants	10 participants n=4 Participants	18 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to one or six months post procedure depending on the event

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Proportion of Subjects in Each Arm That Experience Safety Composite Events	1 Participants	3 Participants

PRIMARY outcome

Timeframe: Minimum of six months

Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF.

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Proportion of Patients With Chronic Treatment Success	11 Participants	10 Participants

SECONDARY outcome

Timeframe: 6 months

Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms.

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline Office Systolic BP	-11.6 mmHg Standard Deviation 16.7	-13.3 mmHg Standard Deviation 16.8
Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline Office Diastolic BP	-5.6 mmHg Standard Deviation 11.6	-5.8 mmHg Standard Deviation 10.0

SECONDARY outcome

Timeframe: 6 months

Compare the difference in heart rate using the 6 month follow-up measurement and baseline visit measurement. These values will then be compared between study arms.

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Difference in Heart Rate at 6 Months and Baseline	-1.9 beats per minute Standard Deviation 17.3	1.8 beats per minute Standard Deviation 16.5

SECONDARY outcome

Timeframe: Procedure

Population: The analysis population for Renal Denervation Procedure and Total Procedure Time does not include participants from the Cryoablation only group since they did not receive the Renal Artery Denervation Procedure.

Elapsed fluoroscopy time and cryocatheter procedure time between study arms. Renal Denervation Procedure Time and Total Procedural Time will be reported only for the Cryoablation and Renal Denervation group.

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Procedural Measures Elapsed Fluoroscopy time	25.4 minutes Standard Deviation 18.9	34 minutes Standard Deviation 19.8
Procedural Measures Cryocatheter Procedure Time	66.2 minutes Standard Deviation 25.6	68.3 minutes Standard Deviation 27.3
Procedural Measures Renal Artery Denervation Procedure Time	—	51.2 minutes Standard Deviation 16.4
Procedural Measures Total Procedure Time	—	119.5 minutes Standard Deviation 35.3

SECONDARY outcome

Timeframe: 6 months

The endpoints for this objective are presence of the following arrhythmic symptoms as recorded at the 6-month visit through discussion with the patient at the time of the visit: * Dizziness * Palpitations * Rapid heart beat * Dyspnea * Fatigue * Syncope * Other

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Proportion of Participants With Symptoms at 6 Months Between Study Arms Dizziness at Baseline	17 Participants	11 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Dizziness at 6 months	6 Participants	4 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Palpitations at Baseline	29 Participants	27 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Palpitations at 6 months	11 Participants	9 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Rapid Heart Beat at Baseline	19 Participants	18 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Rapid Heart Beat at 6 months	4 Participants	6 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Dyspnea at Baseline	25 Participants	21 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Dyspnea at 6 months	6 Participants	7 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Fatigue at Baseline	16 Participants	20 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Fatigue at 6 months	6 Participants	8 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Syncope at Baseline	1 Participants	1 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Syncope at 6 months	0 Participants	0 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Other at Baseline	13 Participants	10 Participants
Proportion of Participants With Symptoms at 6 Months Between Study Arms Other at 6 months	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: If a subject has not used Class I or III anti-arrhythmic drugs at all following the blanking period, all of their follow-up will be used for this analysis. If a subject has used either Class I or Class III anti-arrhythmic drugs after the blanking period, they will be excluded for this analysis.

Compare the rate of chronic treatment success (primary effectiveness endpoint) between study arms for subjects off of Class I and III anti-arrhythmic drugs following the blanking period.

Outcome measures

Outcome measures
Measure	Cryoablation Only n=20 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=24 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period. Treatment Failure	13 Participants	16 Participants
Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period. No Treatment Failure	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 91 days after the cryoablation procedure date until the last Reveal LINQ device data date.

Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms.

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period	2.78 Percent of time Standard Deviation 5.96	1.75 Percent of time Standard Deviation 5.35

POST_HOC outcome

Timeframe: Baseline till end of recording of implantable loop recorder

Calculate the daily atrial arrhythmia burden in hours from baseline to end of the ILR recording. The patients who had a mean burden of 1 or more hours per day on the days they experienced atrial arrhythmias are included in the analysis. From these patients, it is then determined the mean daily atrial arrhythmia burden between groups.

Outcome measures

Outcome measures
Measure	Cryoablation Only n=36 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Daily Atrial Arrhythmia Burden From Baseline to End of ILR Recording for Patients Who Had a Mean Burden of Greater Than or Equal to 1 Hour Per Day on the Days They Experienced Atrial Arrhythmia(s)	9.2 hours Standard Deviation 6	4.1 hours Standard Deviation 3.5

POST_HOC outcome

Timeframe: Baseline till end of follow-up (varies per patient)

Compare the number of patients who discontinued Class I/III anti-arrhythmic drugs between groups

Outcome measures

Outcome measures
Measure	Cryoablation Only n=22 Participants Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=20 Participants Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Number of Patients Who Discontinued Class I/III Anti-arrhythmic Drugs	3 Participants	9 Participants

Adverse Events

Cryoablation Only

Serious events: 17 serious events

Other events: 22 other events

Deaths: 1 deaths

Cryoablation and Renal Nerve Denervation

Serious events: 20 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Vanessa DeBruin

Medtronic, Inc.

Phone: 6123607687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cryoablation Only n=36 participants at risk Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 participants at risk Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Blood and lymphatic system disorders Anaemia	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Acute myocardial infarction	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	5.9% 2/34 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Atrial fibrillation	19.4% 7/36 • Number of events 7 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	26.5% 9/34 • Number of events 10 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Atrial flutter	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	14.7% 5/34 • Number of events 6 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Atrial tachycardia	2.8% 1/36 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Cardiac failure	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Cardiac failure congestive	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Coronary artery disease	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Coronary artery occlusion	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Hypertensive heart disease	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Left ventricular dysfunction	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Mitral valve incompetence	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Pericarditis	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Supraventricular extrasystoles	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Tachycardia	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Ventricular extrasystoles	5.6% 2/36 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Endocrine disorders Thyroid mass	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Eye disorders Cataract	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Gastrointestinal disorders Gastritis erosive	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Chest discomfort	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Chest pain	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Oedema peripheral	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Puncture site hematoma	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Hepatobiliary disorders Cholecystitis acute	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Immune system disorders Hypersensitivity	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Infections and infestations Escherichia sepsis	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Road traffic accident	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Vascular pseudoaneurysm	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Investigations CHA2DS2-VASc annual stroke risk moderate	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Musculoskeletal and connective tissue disorders Osteoarthritis	2.8% 1/36 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Nervous system disorders Cerebrovascular accident	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	5.9% 2/34 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect

Other adverse events
Measure	Cryoablation Only n=36 participants at risk Pulmonary vein isolation Arctic Front Advance™ Cardiac Cryoablation System	Cryoablation and Renal Nerve Denervation n=34 participants at risk Pulmonary vein isolation plus renal nerve denervation Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter Arctic Front Advance™ Cardiac Cryoablation System
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Angina pectoris	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Atrial fibrillation	19.4% 7/36 • Number of events 7 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	11.8% 4/34 • Number of events 8 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Atrial flutter	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	5.9% 2/34 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Atrial tachycardia	5.6% 2/36 • Number of events 3 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Atrioventricular block complete	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Bradycardia	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Coronary artery disease	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Left ventricular hypertrophy	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Pericardial effusion	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Pericarditis	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Sinus arrest	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Sinus bradycardia	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Supraventricular extrasystoles	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Cardiac disorders Tricuspid valve disease	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Ear and labyrinth disorders Vertigo	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Gastrointestinal disorders Diarrhoea	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Gastrointestinal disorders Gastric mucosa erythema	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Application site erythema	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Chest pain	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Fatigue	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Implant site haematoma	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Implant site pain	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Non-cardiac chest pain	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Oedema peripheral	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
General disorders Vessel puncture site haematoma	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Infections and infestations Laryngitis	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Infections and infestations Postoperative wound infection	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Contusion	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Fall	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Incision site oedema	0.00% 0/36 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	5.9% 2/34 • Number of events 2 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Phrenic nerve injury	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Vascular access site haematoma	8.3% 3/36 • Number of events 3 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Injury, poisoning and procedural complications Vascular access site haemorrhage	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Investigations Blood pressure increased	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	2.9% 1/34 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Investigations Cardiac murmur	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect
Investigations Electrocardiogram ST segment elevation	2.8% 1/36 • Number of events 1 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect	0.00% 0/34 • From Subject enrollment through study completion. Study completion varied for each patient based upon when the last patient completed their 6 month follow-up visit. Adverse event that: 1. led to death 2. led to serious deterioration in health of the subject, that resulted in * life-threatening illness or injury, or * permanent impairment of body structure or body function, or * in-patient or prolonged hospitalization, or * medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, b) led to fetal distress, fetal death or congenital abnormality or birth defect