Trial Outcomes & Findings for TactiFlex Paroxysmal Atrial Fibrillation IDE Trial (NCT NCT04356040)

Last Updated: 2023-10-31

Results Overview

Tthe rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below: * Atrio-esophageal fistula1 * Cardiac tamponade/perforation1 * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis1 * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Vascular access complications (including major bleeding events) 1. Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12-months.

Recruitment status

COMPLETED

Study phase

Target enrollment

355 participants

Primary outcome timeframe

Through 12 months

Results posted on

2023-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Paroxysmal AF - Main Study TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	Paroxysmal AF HSP Sub-Study TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
Overall Study STARTED	305	50
Overall Study Device Inserted and RF Energy Delivered	284	50
Overall Study 7-Day Visit	280	50
Overall Study 5-Week Visit	279	50
Overall Study 3-Month Visit	272	50
Overall Study 6-Month Visit	267	49
Overall Study 12-Month Visit	264	48
Overall Study COMPLETED	268	48
Overall Study NOT COMPLETED	37	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Paroxysmal AF - Main Study TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	Paroxysmal AF HSP Sub-Study TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
Overall Study Death	2	0
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	13	1
Overall Study Enrollment Pause	10	0
Overall Study Did not meet Inclusion/Exclusion criteria	7	0
Overall Study Procedure aborted prior to device insertion into the vasculature	1	0
Overall Study PI left institution	3	0

Baseline Characteristics

TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paroxysmal AF - Main Study n=284 Participants TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	Paroxysmal AF HSP Sub-Study n=50 Participants TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.	Total n=334 Participants Total of all reporting groups
Age, Continuous	65.0 years n=5 Participants	67.0 years n=7 Participants	65.0 years n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	16 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	180 Participants n=5 Participants	34 Participants n=7 Participants	214 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	264 Participants n=5 Participants	45 Participants n=7 Participants	309 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	262 Participants n=5 Participants	44 Participants n=7 Participants	306 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Austria	29 participants n=5 Participants	0 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Hong Kong	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment United States	185 participants n=5 Participants	50 participants n=7 Participants	235 participants n=5 Participants
Region of Enrollment Czechia	7 participants n=5 Participants	0 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Taiwan	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Italy	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Australia	31 participants n=5 Participants	0 participants n=7 Participants	31 participants n=5 Participants
Region of Enrollment Germany	22 participants n=5 Participants	0 participants n=7 Participants	22 participants n=5 Participants
Body Mass Index	28.4 kg/m^2 n=5 Participants	28.35 kg/m^2 n=7 Participants	28.4 kg/m^2 n=5 Participants
CHA2DS2Vasc Score	2 units on a scale n=5 Participants	2 units on a scale n=7 Participants	2 units on a scale n=5 Participants
New York Heart Association Functional Classification No Heart Failure	203 Participants n=5 Participants	44 Participants n=7 Participants	247 Participants n=5 Participants
New York Heart Association Functional Classification Class I	54 Participants n=5 Participants	1 Participants n=7 Participants	55 Participants n=5 Participants
New York Heart Association Functional Classification Class II	27 Participants n=5 Participants	5 Participants n=7 Participants	32 Participants n=5 Participants
New York Heart Association Functional Classification Class III or IV	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Left Ventricular Ejection Fraction	60.0 Percentage n=5 Participants	55.0 Percentage n=7 Participants	60.0 Percentage n=5 Participants
Left Atrial Diameter	40.0 Millimeters n=5 Participants	40.0 Millimeters n=7 Participants	40.0 Millimeters n=5 Participants

PRIMARY outcome

Timeframe: Through 12 months

Population: The primary safety analysis population for the primary safety endpoint included all treated subjects 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.

Outcome measures

Outcome measures
Measure	Main Study n=280 Participants TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	High Standard Power Sub-Study n=50 Participants TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
Number of Participants With Device or Procedure-related Serious Adverse Events	12 Participants	2 Participants

PRIMARY outcome

Timeframe: Through 12 months

Population: All treated subjects

Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period will not be considered a treatment failure. One repeat procedure will be allowed during the blanking period. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed drugs are taken at doses that do not exceed the previously failed dose.

Outcome measures

Outcome measures
Measure	Main Study n=284 Participants TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	High Standard Power Sub-Study n=50 Participants TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence	72.9 percentage Interval 67.2 to 78.6	71.8 percentage Interval 57.0 to 86.6

SECONDARY outcome

Timeframe: Through 12 months

Population: All Treated Subjects

Freedom from documented symptomatic atrial fibrillation/atrial flutter/atrial tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmias drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmias drugs are taken at doses that do not exceed the previously failed dose.

Outcome measures

Outcome measures
Measure	Main Study n=284 Participants TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	High Standard Power Sub-Study n=50 Participants TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence	80.4 percentage Interval 75.2 to 85.6	75.9 percentage Interval 61.5 to 90.3

SECONDARY outcome

Timeframe: 12 months

Population: All treated subjects

Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. Any repeat ablation procedure in the left atrium will be considered a treatment failure. Failure to achieve acute procedural success during the ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmic drugs are taken at doses that do not exceed the previously failed dose.

Outcome measures

Outcome measures
Measure	Main Study n=284 Participants TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	High Standard Power Sub-Study n=50 Participants TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure	71.5 percentage Interval 65.7 to 77.3	71.8 percentage Interval 57.0 to 86.6

SECONDARY outcome

Timeframe: Through 12 months

Population: All treated subjects

Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up (9 months after a 90-day blanking period). Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, any use of a Class I or III anti-arrhythmic drugs will count as an effectiveness failure.

Outcome measures

Outcome measures
Measure	Main Study n=284 Participants TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	High Standard Power Sub-Study n=50 Participants TactiFlex SE - High Standard Power: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs	64.0 percentage Interval 58.0 to 70.0	65.8 percentage Interval 50.9 to 80.7

Adverse Events

Paroxysmal AF - Main Study

Serious events: 65 serious events

Other events: 5 other events

Deaths: 2 deaths

Paroxysmal AF HSP Sub-Study

Serious events: 8 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paroxysmal AF - Main Study n=284 participants at risk TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	Paroxysmal AF HSP Sub-Study n=50 participants at risk TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
Infections and infestations Infection	3.2% 9/284 • Number of events 10 • 12 months	4.0% 2/50 • Number of events 2 • 12 months
Cardiac disorders Arrhythmia Pre-Existing	2.8% 8/284 • Number of events 8 • 12 months	0.00% 0/50 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer/Non-Malignant Tumor	1.4% 4/284 • Number of events 4 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Pericarditis	1.4% 4/284 • Number of events 4 • 12 months	0.00% 0/50 • 12 months
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	1.4% 4/284 • Number of events 4 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
Cardiac disorders Chest Pain/Angina (Cardiac)	1.1% 3/284 • Number of events 3 • 12 months	0.00% 0/50 • 12 months
Musculoskeletal and connective tissue disorders Musculoskeletal Disorder	1.1% 3/284 • Number of events 3 • 12 months	0.00% 0/50 • 12 months
Vascular disorders Vascular Access Complications	1.1% 3/284 • Number of events 3 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Cardiac Tamponade	0.70% 2/284 • Number of events 2 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
Vascular disorders Coronary Artery Disease	0.70% 2/284 • Number of events 2 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
General disorders Pain (Non-Cardiac)	0.70% 2/284 • Number of events 2 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
Cardiac disorders Pericardial Effusion	0.70% 2/284 • Number of events 2 • 12 months	0.00% 0/50 • 12 months
General disorders Syncope/Dizziness	0.70% 2/284 • Number of events 2 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Thrombosis/Thrombus	0.35% 1/284 • Number of events 2 • 12 months	0.00% 0/50 • 12 months
Skin and subcutaneous tissue disorders Vascular Bleeding/Local Hematomas Ecchymosis	0.70% 2/284 • Number of events 2 • 12 months	0.00% 0/50 • 12 months
General disorders Abnormal Labs (e.g., Creatine phosphokinase, Creatinine, Troponin)	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Arrhythmia New	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Atrioventricular Block/Bundle Branch Block	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Blood and lymphatic system disorders Bleeding/Anemia	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Cardiac Perforation/Injury	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Blood and lymphatic system disorders Cerebrovascular Accident/Stroke	0.35% 1/284 • Number of events 1 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
Endocrine disorders Endocrine Disease/Disorder	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Heart Failure/Pump Failure	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Nervous system disorders Nerve System Damage/Injury/Disease	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Renal and urinary disorders Renal Decompensation/Kidney Injury	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Blood and lymphatic system disorders Transient Ischemic Attack	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Valvular Damage or Insufficiency	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Injury, poisoning and procedural complications Vascular Damage (e.g., Perforation, Dissection, Obstruction)	0.35% 1/284 • Number of events 1 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
General disorders Vasovagal Reaction	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
General disorders Volume Overload	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Eye disorders Abnormal Vision	0.00% 0/284 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
Surgical and medical procedures Elective Procedure/Surgery	0.00% 0/284 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
General disorders Other: Diarrhea	0.00% 0/284 • 12 months	2.0% 1/50 • Number of events 1 • 12 months
Renal and urinary disorders Other: Urinary/Urine Retention	1.1% 3/284 • Number of events 3 • 12 months	0.00% 0/50 • 12 months
Gastrointestinal disorders Other: Abdominal Pain	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Other: Aortic Stenosis	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Other: Atrial Fibrillation	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Respiratory, thoracic and mediastinal disorders Other: Collapsed Lung	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
General disorders Other: Motorcycle Crash	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Cardiac disorders Other: Pericardial-Esophageal Fistula	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Injury, poisoning and procedural complications Other: Pseudoaneurysm of Common Femoral Artery	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Respiratory, thoracic and mediastinal disorders Other: Pulmonary Sarcoidosis	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
General disorders Other: Spontaneous Subarachnoid Hemorrhage	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
Renal and urinary disorders Other: Ureteral Calculus/Stone	0.70% 2/284 • Number of events 2 • 12 months	0.00% 0/50 • 12 months
Renal and urinary disorders Other: Urinary Frequency Needing transurethral resection of the prostate	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months
General disorders Other: Urinary Retention with Acute Kidney Injury	0.35% 1/284 • Number of events 1 • 12 months	0.00% 0/50 • 12 months

Other adverse events

Other adverse events
Measure	Paroxysmal AF - Main Study n=284 participants at risk TactiFlex SE: Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.	Paroxysmal AF HSP Sub-Study n=50 participants at risk TactiFlex SE - HSP: Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
Endocrine disorders Volume Overload	1.8% 5/284 • Number of events 5 • 12 months	6.0% 3/50 • Number of events 3 • 12 months

Additional Information

Anne Sarver

Abbott

Phone: 6517563813

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The data and results from the clinical investigation are the sole property of the Sponsor. The Investigators will not use this clinical investigation-related data without the written consent of the Sponsor for any purpose other than for clinical investigation completion or for generation of publication materials, as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be published or presented before the multi-center results.
Publication restrictions are in place

Restriction type: OTHER