Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong

NCT04096963 | Completed Results FDA Device

• 1 other identifier: S2461
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to observe the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation to reduce the risk of stroke in Hong Kong area.

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  The occurrence of non-effective LAA closure defined as any peri-device flow \> 5mm demonstrated by TEE/CT/MRI at First Follow-up.

  First Follow-up (30 ~ 100 days);

• Primary Safety Endpoint

  The occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are excluded from this endpoint.

  First Follow-up (30-100 days)

Secondary Outcomes (1)

• Secondary Endpoint

  12-Month Follow-up (365 ± 30 days)

Study Arms (1)

The WATCHMAN FLX Delivery System

Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion;

Device: The WATCHMAN FLX Delivery System

Interventions

The WATCHMAN FLX Delivery System DEVICE

WATCHMAN FLX Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium

The WATCHMAN FLX Delivery System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with non-valvular atrial fibrillation to reduce the risk of stroke

You may qualify if:

• Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion;
• Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
• Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

You may not qualify if:

• Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
• The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

Results Point of Contact

• Title: Associate Clinical Trial Manager
• Organization: Boston Scientific Corperation

yifan.zhao@bsci.com

+861085742971

Study Officials

• Chan Chin Pang Gary

  Prince of Wales Hospital

  PRINCIPAL INVESTIGATOR

• Fung Chi Yan Raymond

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Tsui Kin Lam

  Pamela Youde Nethersole Hospital

  PRINCIPAL INVESTIGATOR

• Simon Lam

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

• SF Chui

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: June 19, 2020
• Primary Completion: January 24, 2022
• Study Completion: March 28, 2023
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)