3D Printing Technology For Planning Left Atrial Appendage Occlusion

NCT07483008 | Completed DMC

• 1 other identifier: 2017.397-T
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation is the most common cardiac arrhythmia, affecting 8.5% of the general population in Hong Kong. Systemic embolization, and particularly stroke, is the most frequent major complication of atrial fibrillation. Long-term oral anticoagulation is recommended for most atrial fibrillation patients for prevention of embolism. However, such therapy is associated with an increased risk of bleeding and not all individuals are candidates for this therapy. The left atrial appendage (LAA) is the usual source for clot that embolizes. Occlusion of the LAA ostium (LAAO) with percutaneous device in patients with nonvalvular atrial fibrillation has emerged as an alternative to anticoagulation for prevention of embolism. Procedural success requires careful planning and understanding of the anatomy of LAA, as well as the interaction between the appendage and the occlusion device. However, complexity and variability of LAA anatomy exists and these anatomical variations among individuals poses challenges to accurately sizing and positioning the device. Certain anatomic variations of the appendage, for instance the presence of a sharp bend in the proximal or middle portion of the dominant lobe, or prominent pectinate muscles, pose particular challenge to device implantation and demands pre-specified implantation technique. Assessment of LAA anatomy relies on imaging, usually combining peri-interventional 2D transesophageal echocardiography (TEE) with fluoroscopy guidance and, less frequently, with pre-interventional computed tomography (CT). Because lobes of the LAA exist in different planes, imaging must be done in multiple planes to visualize the entire LAA. Even with advanced imaging, complete understanding the 3D geometry of the appendage is challenging, and the mechanical interaction between the device and the anatomy is difficult to predict or quantify. The limitation of imaging in the assessment of LAA anatomy may lead to inaccurate device sizing. Over- or under-sizing increase the chance of pericardial effusion, incomplete occlusion, and device embolization. Incomplete occlusion of the LAA ostium is common and may jeopardise the procedural efficacy in embolism prevention. Device re-sizing during procedure prolongs procedural time as well as radiation exposure; moreover, device re-positioning within the appendage may cause inadvertent tissue injury and increase the risk of cardiac perforation. Indeed, procedural complication rate of LAAO remains fairly high in real-world practice. 3D printing (3DP) is a novel technology able to create a patient-specific model of any given anatomical portion of the heart for preoperative device testing and procedural simulation. The simulation "rehearsal" experience can enhance the operator's confidence, allowing the operator to anticipate difficulties before the actual intervention; this potentially reduces the procedural time (hence cost and radiation hazard), device re-sizing, the number of deployment attempts, and promotes procedural success. The aim of this project is to evaluate the effect of 3D-printed patient-specific LAA model compared with standard imaging planning on procedural efficacy and safety of LAAO. The project will be divided into two parts: Part I Technical validation of 3D-printed LAA models Validation of anatomical accuracy and material properties of the 3D-printed LAA model will be conducted in 30 patients referred for clinically indicated surgical excision of the LAA. Part II Randomised clinical trial on additive benefit of 3D printing for LAAO. The investigators will conduct a randomized, controlled, open-label, trial in 200 patients undergoing LAAO for stroke prevention in our hospital. Eligible subjects will be randomly assigned by a computer program in a 1:1 ratio to either preoperative planning using 3D-printed LAA model (3D printing arm) or standard imaging planning alone (no-3D printing arm). The investigators hypothesize that preoperative 3DP planning could help in finding the correct position within LAA, sizing the device and guiding the choice of the closure device despite the measurements provided by imaging alone.

Conditions

Atrial Fibrillation (AF); 3D Printing; Cost Benefit Analysis

Keywords

3D printing; Left Atrial Appendage Occlusion; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• To assess the rate of complete occlusion of the ostium

  This will be determined by the absence of peri-device flow on color Doppler imaging or if the jet width is less than 1 mm.

  The occlusion rate will be assessed during the procedure and at the 45-day TEE follow-up

Secondary Outcomes (1)

• Procedural complications

  During the procedure

Other Outcomes (11)

• Procedural time

  During the procedure

• Fluoroscopic time

  During the procedure

• Radiation Exposure

  During the procedure

Study Arms (2)

3D printing arm

ACTIVE COMPARATOR

In the 3D printing arm, pliable 3D-printed LAA models will be created 1 week before the planned LAAO procedure using methodology described above. Preoperative procedural simulation will be conducted by testing different types (Watchman \[Boston Scientific Inc.\] and Amplatzer Amulet \[St Jude Inc.\]) and sizes (21-33mm for Watchman, 16-34mm for Amulet) of locally available LAAO devices on the 3D-printed pliable appendage model to determine the optimal device type and size that achieve proper positioning, stability, and complete occlusion of the ostium.

Device: 3D-printed models of the left atrial appendage

Non 3D printing arm

OTHER

In the no-3D printing arm, standard preoperative planning based on preoperative imaging, namely, multi-planar 2D/3D TEE and, in selected cases at the physician's discretion, pre-interventional CT.

Other: Standard preoperative planning

Interventions

3D-printed models of the left atrial appendage DEVICE

Participants receive preoperative planning using patient-specific 3D-printed models of the left atrial appendage. This arm includes procedural simulation with different occlusion devices and sizes to optimize the intervention.

3D printing arm

Standard preoperative planning OTHER

Participants undergo standard preoperative planning based solely on traditional imaging techniques, such as 2D/3D transesophageal echocardiography (TEE) and optionally computed tomography (CT).

Non 3D printing arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Non-valvular atrial fibrillation
• CHA2DS2-VASc ≥2
• Absolute or relative contraindications to long-term oral anticoagulation (e.g. history of intracranial or life-threatening bleeding, HAS-BLED ≥3, triple anticoagulant therapy)
• Planned for LAAO procedure

You may not qualify if:

• Intracardiac thrombus is visualized by echocardiographic imaging
• An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present
• The LAA anatomy will not accommodate a device
• Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
• Known hypersensitivity to any portion of the device material or the individual components
• Comorbidities other than atrial fibrillation that required oral anticoagulation
• Suboptimal LAA image on TEE or CT that is inadequate for 3D modelling and printing
• Refusal to participate the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Division of Cardiology, Department of Medicine and Therapeutics Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, New Territories, Sha Tin, Hong Kong

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex PW Lee, Professor

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 19, 2026
• Study Start: October 1, 2017
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)