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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03795298




Registration number
NCT03795298
Ethics application status
Date submitted
2/01/2019
Date registered
7/01/2019

Titles & IDs
Public title
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Scientific title
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Secondary ID [1] 0 0
S2239
Universal Trial Number (UTN)
Trial acronym
OPTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - WATCHMAN FLX Implant
Treatment: Drugs - Market-approved OAC

Experimental: WATCHMAN FLX - WATCHMAN FLX implant including modified post-implant drug regimen.

Active comparator: Market-approved OAC - Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.


Treatment: Devices: WATCHMAN FLX Implant
Left atrial appendage closure with the WATCHMAN FLX device

Treatment: Drugs: Market-approved OAC
Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stroke, all cause death, and systemic embolism
Timepoint [1] 0 0
36 months
Primary outcome [2] 0 0
Non-procedural bleeding
Timepoint [2] 0 0
36 months
Secondary outcome [1] 0 0
Major bleeding
Timepoint [1] 0 0
36 months

Eligibility
Key inclusion criteria
1. The subject is of legal age to participate in the study per the laws of their respective geography.
2. Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant).
3. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
4. The subject is deemed to be suitable for the defined protocol pharmacologic regimen.
5. The subject is able to undergo TEE examinations.
6. The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.
7. The subject is able and willing to return for required follow-up visits and examinations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The subject is currently enrolled in another investigational study that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
2. The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy).
3. The subject is deemed by the treating physician to be unsuitable for chronic anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other reasons.
4. The subject had or is planning to have any cardiac or major non-cardiac interventional or surgical procedure (excluding non-valvular AF ablation and cardioversion) within 30 days prior to or 60 days after randomization [including, but not limited to: percutaneous coronary intervention (PCI), other cardiac ablation (VT ablation, etc.), etc.].
5. The subject had a stroke or transient ischemic attack (TIA) within the 60 days prior to randomization.
6. The subject had a prior major bleeding event per ISTH definition within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
7. The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to randomization.
8. The subject has a history of atrial septal repair or has an ASD/PFO device.
9. The subject has an implanted mechanical valve prosthesis in any position.
10. The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion)
11. The subject has a documented life expectancy of less than two years.
12. The subject has a cardiac tumor.
13. The subject has signs/symptoms of acute or chronic pericarditis.
14. There is evidence of tamponade physiology.
15. Contraindications (anatomical or medical) to percutaneous catheterization procedures.
16. The subject has documented NYHA Class IV heart failure.
17. The subject has documented surgical closure of the left atrial appendage.
18. The subject has an active infection.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/07/2024
Sample size
Target
Accrual to date
Final
1600
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Advara HeartCare - Brisbane
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
4120 QLD - Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Oussama Wazni, MD
Address 0 0
The Cleveland Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03795298