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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03795298
Ethics application status
Date submitted
2/01/2019
Date registered
7/01/2019
Date last updated
9/10/2020

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 - WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism.
Timepoint [1] 0 0
36 months
Primary outcome [2] 0 0
Non-procedural bleeding - WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).
Timepoint [2] 0 0
36 months
Secondary outcome [1] 0 0
Major bleeding - WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Heart Care Partners - Brisbane
Recruitment postcode(s) [1] 0 0
4120 QLD - Brisbane
Recruitment outside Australia
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Alabama
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Belgium
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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
The primary objective of this study is to determine if left atrial appendage closure with the
WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following
percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
Trial website
https://clinicaltrials.gov/show/NCT03795298
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
Jennifer L Williams
Address 0 0
Country 0 0
Phone 0 0
1-800-CARDIAC
Fax 0 0
Email 0 0
Jennifer.williams2@bsci.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03795298