Trial Outcomes & Findings for Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis (NCT NCT02905240)

Last Updated: 2023-11-07

Results Overview

The primary objective of this study was to determine whether nSTRIDE APS is superior to Saline with respect to the improvement in mean WOMAC Pain score (change from baseline to 12 Months post-injection raw score). The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).

Recruitment status

COMPLETED

Study phase

Target enrollment

332 participants

Primary outcome timeframe

Baseline and 12 Months

Results posted on

2023-11-07

Participant Flow

During the screening process, potential subjects provided informed consent and were then screened for eligibility. Screening consisted of meeting all inclusion and exclusion criteria, including a WOMAC LK 3.1 pain subscale score ≥ 9 and ≤ 19 and by providing objective physiological evidence of OA using the Kellgren-Lawrence scale (assessed from normal radiographs).

Participant milestones

Participant milestones
Measure	nSTRIDE APS Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline Saline control Saline: single intra-articular injection
Overall Study STARTED	172	160
Overall Study COMPLETED	154	137
Overall Study NOT COMPLETED	18	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	nSTRIDE APS n=172 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=160 Participants Saline control Saline: single intra-articular injection	Total n=332 Participants Total of all reporting groups
Race/Ethnicity, Customized White (Hispanic)	21 Participants n=5 Participants	7 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized White (Non-Hispanic)	125 Participants n=5 Participants	135 Participants n=7 Participants	260 Participants n=5 Participants
Region of Enrollment United States	172 participants n=5 Participants	160 participants n=7 Participants	332 participants n=5 Participants
WOMAC Pain	11.27 points STANDARD_DEVIATION 2.23 • n=5 Participants	11.37 points STANDARD_DEVIATION 2.11 • n=7 Participants	11.32 points STANDARD_DEVIATION 2.17 • n=5 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	58.6 years STANDARD_DEVIATION 9.6 • n=7 Participants	58.55 years STANDARD_DEVIATION 9.95 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	90 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	70 Participants n=7 Participants	162 Participants n=5 Participants
Race/Ethnicity, Customized African-American	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Not Specified	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 Months

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=172 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=160 Participants Saline control Saline: single intra-articular injection
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months	-5.6 score on a scale Interval -6.3 to -4.9	-5.4 score on a scale Interval -6.2 to -4.6

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Number of subjects with a completed VAS pain score at Baseline and at 12 Months

The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right.

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=149 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=134 Participants Saline control Saline: single intra-articular injection
Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months	-25.8 score on a scale Standard Deviation 27.09	-23.4 score on a scale Standard Deviation 29.14

SECONDARY outcome

Timeframe: 12 months

Population: Number of subjects with complete data at 12 Months to calculate responder status

The OMERACT-OARSI Responder Criteria were applied to both treatment groups, categorizing each patient into one of two categories: responder and non-responder. Responders were defined as subjects who achieved a high degree of improvement in pain or in function (improvement of ≥50% and absolute change ≥20), or a moderate degree of improvement in 2 of the 3 response domains (pain, function, global assessment).

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=149 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=134 Participants Saline control Saline: single intra-articular injection
Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders Responder	101 Participants	92 Participants
Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders Non-Responder	48 Participants	42 Participants

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Number of subjects with a completed WOMAC stiffness score at Baseline and at 12 Months

The WOMAC stiffness subscale consisted of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=149 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=134 Participants Saline control Saline: single intra-articular injection
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months	-2.1 score on a scale Interval -2.4 to -1.8	-2.2 score on a scale Interval -2.6 to -1.9

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Number of subjects with a completed EQ-5D score at Baseline and at 12 Months

The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-3L descriptive component assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over three levels of severity. The EQ visual analogue scale (EQ VAS) assesses the respondent's self-rated overall health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=149 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=134 Participants Saline control Saline: single intra-articular injection
EQ-5D Change From Baseline to 12 Months	4.62 score on a scale Interval 2.02 to 7.22	4.06 score on a scale Interval 1.32 to 6.8

SECONDARY outcome

Timeframe: 12 months

Population: Intent to Treat Population

Subjects experiencing at least one AE

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=172 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=160 Participants Saline control Saline: single intra-articular injection
Adverse Events	94 Participants	93 Participants

POST_HOC outcome

Timeframe: Baseline and 1 Year

Population: Per Protocol population at 12 Months

This criteria is based on the usage of rescue medication and restricted medication/therapy usage and the WOMAC pain subscale percent change from baseline. A patient is considered a non-responder if one or more of the following are true: 1. Early exit for Knee OA per IDMC determination 2. WOMAC Pain Percent improvement 27% 3. Rescue Medication not withheld within 48 hours of the 12 month study visit 4. Medication/therapy violation at the 12 month visit (New or Continuing) 5. Rescue medication taken most days or every day, as reported at the 12 month visit

Outcome measures

Outcome measures
Measure	nSTRIDE APS n=162 Participants Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=151 Participants Saline control Saline: single intra-articular injection
Post-Hoc Pain/Medication Usage Responder Analysis Non-Responder	65 Participants	80 Participants
Post-Hoc Pain/Medication Usage Responder Analysis Responder	97 Participants	71 Participants

Adverse Events

nSTRIDE APS

Serious events: 8 serious events

Other events: 0 other events

Deaths: 1 deaths

Saline

Serious events: 8 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Woodell-May, Research Associate Director

Zimmer Biomet

Phone: 5742651885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	nSTRIDE APS n=172 participants at risk Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection	Saline n=160 participants at risk Saline control Saline: single intra-articular injection
Cardiac disorders Heart Attack	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Investigations Death	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Musculoskeletal and connective tissue disorders Arthralgia	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Musculoskeletal and connective tissue disorders Excessive Pain	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Gastrointestinal disorders GERD and Hiatal Hernia	0.00% 0/172 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Musculoskeletal and connective tissue disorders Right Knee Patella Pain	0.00% 0/172 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Gastrointestinal disorders Perforated Diverticulitis	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Gastrointestinal disorders Acute Cholecystitis	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Gastrointestinal disorders Lap Band Slippage and Diverticulitis	0.00% 0/172 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Psychiatric disorders Confusion, Memory Loss	0.00% 0/172 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Respiratory, thoracic and mediastinal disorders Respiratory Syncytial Virus	0.00% 0/172 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Cardiac disorders Abnormal Cardiac Stress Test	0.00% 0/172 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.62% 1/160 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Hepatobiliary disorders Kidney Stones	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Endocrine disorders Thyroid Mass	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
General disorders Severe Dizziness	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
Cardiac disorders Atrial Fibrillation	0.58% 1/172 • Number of events 1 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.	0.00% 0/160 • All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months. AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.