Here is the design of a clinical trial:

Official Title: The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device (PREDICT-LAA)

Included conditions:
- Atrial Fibrillation
- Stroke Prevention

Study Armgroups:
- {'label': 'Standard of care treatment arm', 'type': 'ACTIVE_COMPARATOR', 'description': "When patients are randomized to the standard treatment arm, patients will be treated according to the participating site's routine practice. As pre-procedural imaging, a cardiac CT-scan has to be performed; this can also be complemented with TEE at the discretion of the operator. The LAA closure procedure should be performed according to routine practice of the participating site - either in general or local anesthesia.\n\nFor those cases randomized to the standard treatment arm, the pre-procedural CT-scans will still be collected at completion of the study and FEops HEARTguideTM simulations will be generated, blinded for the procedural images and outcome. These simulations will be compared with the final device size and implant position and will be used for an additional comparative PREDICT-LAA sub-study.", 'interventionNames': ['Procedure: Left atrial appendage closure']}
- {'label': 'Computational simulation arm', 'type': 'EXPERIMENTAL', 'description': "When patients are randomized to the computational simulation arm, the procedure will still be performed according to the participating site's routine practice - however, the procedure will only be performed after careful review of the FEops HEARTguideTM simulation results. The only prerequisite is that all patients randomized to this arm will have to undergo a pre-procedural cardiac CT-scan that will be uploaded into the FEops HEARTguideTM platform. Following this upload, a pre-procedural simulation plan will be provided to the operator, containing a set of optimal and suboptimal closure device sizes and implant positions. Software and technology upgrades of the FEops HEARTguideTM platform will be allowed during the course of the study.", 'interventionNames': ['Other: Additional support for preoperative planning of LAA closure procedures', 'Procedure: Left atrial appendage closure']}

Interventions:
- {'type': 'OTHER', 'name': 'Additional support for preoperative planning of LAA closure procedures', 'description': 'The results of the computational simulations provided by FEops HEARTguideTM will be used in the "computational simulation arm" as an additional preoperative planning tool and their potential added value will be assessed by comparison to the standard of care arm.', 'armGroupLabels': ['Computational simulation arm']}
- {'type': 'PROCEDURE', 'name': 'Left atrial appendage closure', 'description': 'Transcatheter device insertion to exclude the LAA from the cardiac circulation', 'armGroupLabels': ['Computational simulation arm', 'Standard of care treatment arm']}

Primary Outcomes:
- {'measure': 'Incomplete LAA closure and definite device-related thrombosis (DRT)', 'description': 'The percentage of patients with incomplete LAA closure (defined as any remaining contrast leakage into the LAA distal of the Amulet lobe) and/or a definite DRT at post-procedural cardiac CT imaging at three months after the procedure. Definite DRT is defined as "high-grade" hypo-attenuating thickening at the atrial surface of the closure device - as previously described by Korsholm et al., Circ Cardiovasc Interv, 2019.', 'timeFrame': 'Post-procedural cardiac CT scan at 3 months after LAA closure'}

Please estimate the sample size based on the assumption: 
Power: 0.8, Significance level (Î±): 0.05, Missing/dropout rate: 10% to 15%. The primary endpoint will be analyzed using Fisher's exact test or a χ2 test. Data/statistical analysis will be performed according to the 'intention-to-treat' principle as a first approach and 'as-treated' as a second approach.
Sample size calculation
        The primary endpoint is expected to occur in 30% of patients in the standard treatment arm. An equal number of patients will be enrolled in both treatment arms. A 65% reduction of the primary endpoint requires inclusion of 174 patients in order to demonstrate superiority (power 0.8, Î± 0.05). Taking into account an estimated loss at follow-up of 10% to 15% of patients (due to mortality and inconclusive CCT imaging at 3 months postprocedure), the total sample size needed to demonstrate superiority has been calculated to be 200 patients. The primary endpoint will be analysed using Fisherâs exact test or a Ï2 test, as required. Data/statistical analysis will be performed according to the âintention-to-treatâ principle as a first approach and âas-treatedâ as a second approach.