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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04356040
Registration number
NCT04356040
Ethics application status
Date submitted
15/04/2020
Date registered
21/04/2020
Date last updated
31/10/2023
Titles & IDs
Public title
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
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Scientific title
Safety and Effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for Treating Drug-refractory, Symptomatic Atrial Fibrillation.
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Secondary ID [1]
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CRD_978
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Secondary ID [2]
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ABT-CIP-10303
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Paroxysmal Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - TactiFlex SE
Treatment: Devices - TactiFlex SE - High Standard Power
Experimental: Main Study -
Experimental: High Standard Power Sub-Study -
Treatment: Devices: 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.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Device or Procedure-related Serious Adverse Events
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Assessment method [1]
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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)
Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12-months.
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Timepoint [1]
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Through 12 months
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Primary outcome [2]
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KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
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Assessment method [2]
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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.
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Timepoint [2]
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Through 12 months
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Secondary outcome [1]
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KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
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Assessment method [1]
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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.
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Timepoint [1]
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Through 12 months
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Secondary outcome [2]
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KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure
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Assessment method [2]
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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.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs
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Assessment method [3]
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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.
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Timepoint [3]
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Through 12 months
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Eligibility
Key inclusion criteria
A patient will be eligible for clinical trial participation if he/she meets the following
criteria:
1. Plans to undergo a catheter ablation procedure due to symptomatic paroxysmal atrial
fibrillation
2. Physician's note indicating recurrent self-terminating atrial fibrillation
3. One electrocardiographically documented atrial fibrillation episode within 12-months
prior to informed consent/enrollment. Documented evidence of the atrial fibrillation
episode must either be continuous atrial fibrillation on a 12-lead ECG or include at
least 30 seconds of atrial fibrillation from another ECG device.
4. At least 18 years of age
5. Able and willing to comply with all trial requirements
6. Informed of the nature of the trial, agreed to its provisions and has provided written
informed consent as approved by the Institutional Review Board/Ethics Committee of the
respective clinical trial site.
A patient will be excluded from enrollment in the clinical trial if he/she meets any of the
following criteria:
1. Persistent or long-standing persistent atrial fibrillation
2. Active systemic infection
3. Known presence of cardiac thrombus
4. Hypertrophic cardiomyopathy
5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol
intoxication, and other major surgical procedures in the 90-day period preceding
procedure
6. Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or
valve or coronary bypass grafting surgery within 90 days of procedure
7. Left atrial diameter > 5.0 cm measured within 180 days of procedure (echocardiography
or computerized tomography)
8. Left ventricular ejection fraction < 35% measured within 180 days of procedure
(echocardiography or computerized tomography)
9. New York Heart Association class III or IV
10. Previous left atrial surgical or catheter ablation procedure
11. Left atrial surgical procedure or incision with resulting scar (including left atrial
appendage closure device)
12. Previous tricuspid or mitral valve replacement or repair
13. Heart disease in which corrective surgery is anticipated within 180 days after the
procedure
14. Bleeding diathesis or suspected pro-coagulant state
15. Contraindication to long term anti-thromboembolic therapy
16. Presence of any condition that precludes appropriate vascular access
17. Renal failure requiring dialysis
18. Known sensitivity to contrast media (if needed during the procedure) that cannot be
controlled with pre-medication
19. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic
obstructive pulmonary disease) or any other disease or malfunction of the lungs or
respiratory system that produces severe chronic symptoms
20. Women who are pregnant or breastfeeding
21. Presence of other anatomic or comorbid condition that, in the investigator's opinion,
could limit the patient's ability to participate in the clinical trial or to comply
with follow up requirements, or impact the scientific soundness of the clinical trial
results
22. Patient is currently participating in another clinical trial or has participated in a
clinical trial within 30 days prior to screening that may interfere with this clinical
trial
23. Patient is unlikely to survive the protocol follow up period of 12-months after the
procedure
24. Body mass index > 40 kg/m2
25. Presence of other medical, social, or psychological conditions that, in the
investigator's opinion, could limit the subject's ability to participate in the
clinical investigation or to comply with follow-up requirements, or impact the
scientific soundness of the clinical investigation results.
26. Individuals without legal authority
27. Individuals unable to read or write
28. Patients who have had a ventriculotomy or atriotomy within the preceding 4 weeks of
procedure,
29. Patients with prosthetic valves,
30. Patients with a myxoma,
31. Patients with an interatrial baffle or patch as the transseptal puncture could persist
and produce an iatrogenic atrial shunt
32. Patient unable to receive heparin or an acceptable alternative to achieve adequate
anticoagulation
33. Stroke or transient ischemic attack within the last 90 days
34. Stent, constriction, or stenosis in a pulmonary vein.
35. Rheumatic heart disease
36. Severe mitral regurgitation (regurgitant volume = 60 mL/beat, regurgitant fraction =
50%, and/or effective regurgitant orifice area = 0.40cm2).
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Minimum age
18
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Maximum age
99
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2022
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Sample size
Target
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Accrual to date
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Final
355
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Recruitment in Australia
Recruitment state(s)
NSW,QueenslVictor
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment hospital [2]
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Wesley Private Hospital - Auchenflower
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The Prince Charles Hospital - Chermside
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Monash Medical Centre - Clayton
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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4032 - Chermside
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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5067 - Adelaide
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Colorado
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Florida
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Idaho
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Indiana
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Upr Aus
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Ontario
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Leipzig
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Hong Ko
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Taiwan
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Ntaiwan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study
design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2)
Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study
cohorts are to be treated using the full range of ablation power settings in the Instructions
For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of
the recommended ablation power settings (40-50 Watts).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04356040
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Kristin Ruffner, PhD
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Address
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Clinical Program Director
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04356040
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