Trial Outcomes & Findings for Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (NCT NCT03650556)

Last Updated: 2022-04-27

Results Overview

Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.

Recruitment status

COMPLETED

Study phase

Target enrollment

224 participants

Primary outcome timeframe

Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure

Results posted on

2022-04-27

Participant Flow

A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria

One subject was withdrawn after meeting enrollment criteria but prior to procedure with the investigational device.

Participant milestones

Participant milestones
Measure	Enrolled A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Overall Study STARTED	224
Overall Study Ablation Procedure	223
Overall Study Pre-Discharge	223
Overall Study 7-day Follow-Up	223
Overall Study 3-month Follow-Up	210
Overall Study 6-month Follow-up	197
Overall Study 12-month Follow-Up	189
Overall Study 15-month Follow-Up	187
Overall Study COMPLETED	187
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Overall Study Death	2
Overall Study Withdrawal by Subject	20
Overall Study Physician Decision	2
Overall Study Lost to Follow-up	8
Overall Study Subject did not complete follow-up but did not meet criteria for lost-to-follow-up	4
Overall Study Enrolled, but no ablation performed-investigational catheter was not inserted	1

Baseline Characteristics

Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ablation n=223 Participants All enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment
Age, Continuous	65.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	209 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	213 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	209 Participants n=5 Participants
Region of Enrollment Australia	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days of initial or repeat procedure performed ≤180 days of initial procedure

Population: The analysis population for the primary safety endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 7-day follow-up visit; or crossed the end of the 7-day visit window without the visit but with a primary safety endpoint event

Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.

Outcome measures

Outcome measures
Measure	Enrolled n=223 Participants A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Rate of Subjects With a Device and/or Procedure-related SAE.	7 Participants

PRIMARY outcome

Timeframe: 15 months

Population: The analysis population for the primary effectiveness endpoint is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.

The following events were considered a failure for AF/AFL/AT recurrence: * If AF/AFL/AT recurrence (\>30 second episode) occurred at any time after the therapy consolidation period (\>180 days after the initial procedure), or * If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a \>30 second AF/AFL/AT episode, or * If the subject required a second repeat procedure at any time after the initial procedure, or * If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or * If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or * If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the

Outcome measures

Outcome measures
Measure	Enrolled n=190 Participants A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.	114 Participants

SECONDARY outcome

Timeframe: Immediate post procedure

Population: The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment

Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins

Outcome measures

Outcome measures
Measure	Enrolled n=223 Participants A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Acute Procedural Success	219 Participants

SECONDARY outcome

Timeframe: 15 months

Population: The analysis population is all enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment and who have completed their 15-month ECG, TTM, and/or 24-hour Holter assessment; or crossed the end of the 15-month visit window without the ECG, TTM and/or 24-hour Holter assessment but with a prior primary effectiveness endpoint event.

Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods.

Outcome measures

Outcome measures
Measure	Enrolled n=190 Participants A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
15-month Success Off of Antiarrhythmic Drugs	89 Participants

SECONDARY outcome

Timeframe: 15 months

Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes \>30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.

Outcome measures

Outcome measures
Measure	Enrolled n=190 Participants A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
15 Month Single Procedure Success	110 Participants

Adverse Events

Enrolled

Serious events: 59 serious events

Other events: 29 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Enrolled n=224 participants at risk A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Cardiac disorders Arrhythmia	4.0% 9/224 • Number of events 9 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Bleeding/Anemia	2.2% 5/224 • Number of events 5 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Nervous system disorders Cerebrovascular Accident/Stroke	0.89% 2/224 • Number of events 3 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Coronary Artery Thrombosis/Occlusion	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Elective Procedure/Surgery	2.2% 5/224 • Number of events 5 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Heart Failure/Pump Failure	1.3% 3/224 • Number of events 3 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Hypertension	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Infection	1.8% 4/224 • Number of events 4 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Renal and urinary disorders Renal Decompensation/Acute Kidney Injury	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Respiratory Compromise/Decompensation	0.89% 2/224 • Number of events 2 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Shock	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Syncope/Dizziness	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Valve Insufficiency	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Volume Overload	1.3% 3/224 • Number of events 3 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Acute Ischemic Colitis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Bowel Obstruction	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Bradycardia	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Cholecystitis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Collapse	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Colon Obstruction	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Musculoskeletal and connective tissue disorders Fracture of Humerous	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Lower GI Bleed	0.89% 2/224 • Number of events 2 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Pelvic Inflammatory Disease	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Reproductive system and breast disorders Penile Fracture	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Rectal and Vaginal Prolapse Repair	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Musculoskeletal and connective tissue disorders Right Hip Fracture	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Sick Sinus Symptom	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Sinus Bradycardia	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Sudden Cardiac Death	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Trauma	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Renal and urinary disorders Urinary Retention	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Urosepsis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Immune system disorders Allergic Reaction	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Chest Pain/Discomfort	3.6% 8/224 • Number of events 8 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Cardiac Perforation or Tamponade	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Gastroparesis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Pericardial Effusion	1.3% 3/224 • Number of events 3 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Pneumonia	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Psychiatric disorders Encephalopathy	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Jaw and Neck Pain	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Tracheobronchitis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Hypotension	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Colitis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.

Other adverse events

Other adverse events
Measure	Enrolled n=224 participants at risk A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria
Injury, poisoning and procedural complications Air Embolism	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Arrhythmia	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Chest Pain/Discomfort	2.2% 5/224 • Number of events 5 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Infections and infestations Infection	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Pericardial Effusion	0.89% 2/224 • Number of events 2 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Pericarditis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Blood and lymphatic system disorders Thrombosis/Thrombus	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Transient Ischemic Attack	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Vascular Access Complication	0.89% 2/224 • Number of events 2 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Vascular Bleeding/Local Hematoma/Ecchymosis	2.2% 5/224 • Number of events 5 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Vascular disorders Volume Overload	1.3% 3/224 • Number of events 3 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Cardiac disorders Congestive Heart Failure	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Cough	0.89% 2/224 • Number of events 2 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Blood and lymphatic system disorders Elevated Troponin	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Gastrointestinal disorders Esophageal Inflammation	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Fluid Retention	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Headache	0.89% 2/224 • Number of events 2 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Hepatobiliary disorders Hepatohepatomegaly With Elevated Liver Enzymes	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
General disorders Jaw Pain	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Musculoskeletal and connective tissue disorders Shoulder Blade/ Arm Pit Pain	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Blood and lymphatic system disorders Trochanteric Bursitis	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Renal and urinary disorders Urinary Retention	0.45% 1/224 • Number of events 1 • 15 months An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.

Additional Information

Amber Miller

Abbott Medical

Phone: (612) 413-7236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place