Non-valvular Atrial FibrillationNCT04096963

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

An observational study of Non-valvular Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Non-valvular Atrial Fibrillation
What is being tested?: The WATCHMAN FLX Delivery System
Type of treatment: Medical device
How many people: 50 participants
Where: 1 siteChina
Study dates: 19 Jun 2020to 28 Mar 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Queen Mary Hospital
Hong Kong

Other trials in China

About this study

Official title: 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

Read the detailed description

This study is a prospective, non-randomized, multi-center observational study. The primary Effectiveness Endpoint is the occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up.The primary safety endpoint is 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. Secondary effectiveness endpoint is the occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant.

Conditions: Non-valvular Atrial Fibrillation
Being tested: The WATCHMAN FLX Delivery System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04096963
Study group	Role	What they receive
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; Receives: Device: The WATCHMAN FLX Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: First Follow-up (30-100 days)

Secondary outcomes (1)

Secondary Endpoint
The occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant.
Measured: 12-Month Follow-up (365 ± 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 202028 Mar 2023

First posted20 Sep 2019
Study start19 Jun 2020
Primary completion24 Jan 2022
Study completion28 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04096963
Sponsor's protocol ID: S2461
Status last verified: Mar 2024
First submitted: 18 Sep 2019
Last updated: 12 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Active, not recruiting
CHAMPION-AF Clinical Trial
Atrial Fibrillation, Stroke
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
Non-valvular Atrial Fibrillation (AF)
Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation

All Non-valvular Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04096963
Acronym / sponsor ID: S2461
Conditions: Non-valvular Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 19 Jun 2020 (actual)
Primary completion: 24 Jan 2022 (actual)
Study completion: 28 Mar 2023 (actual)
First posted: 20 Sep 2019 (actual)
Results: Posted 12 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
The WATCHMAN FLX Delivery System	–	Device: The WATCHMAN FLX Delivery SystemPatients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion;

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Subjects with non-valvular atrial fibrillation to reduce the risk of stroke

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The WATCHMAN FLX Delivery SystemWATCHMAN FLX Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium	Device	The WATCHMAN FLX Delivery System

Primary outcome

Primary Effectiveness Endpoint
Time frame: First Follow-up (30 ~ 100 days);
The occurrence of non-effective LAA closure defined as any peri-device flow > 5mm demonstrated by TEE/CT/MRI at First Follow-up.
Primary Safety Endpoint
Time frame: First Follow-up (30-100 days)
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.

1 secondary outcome

Secondary Endpoint
Time frame: 12-Month Follow-up (365 ± 30 days)

Results and safety

Results posted to the registry on 12 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The Subjects Who Complete the Study	50	46

Primary outcome: Primary Effectiveness Endpoint

Time frame: First Follow-up (30 ~ 100 days);. Number (95% Confidence Interval). Unit: percentage of occurence

Measure	The Participant Who is PPS Set. n = 46
Value	0 (0.0 to 7.7)

Population analysed: A total of 46 participants completed the first follow up and belong to PPS set.

Primary outcome: Primary Safety Endpoint

Time frame: First Follow-up (30-100 days). Number (95% Confidence Interval). Unit: percentage of occurence

Measure	The Subjects With No-valvular Atrial Fibrillation Who Implant the WATCHMAN FLX LAAC. n = 50
Value	2.0 (0.1 to 10.6)

Population analysed: T

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 0-12months post LAAC.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Subjects Who Are Attempted or Implanted the WATCHMAN FLX LAAC	23 of 50 (46%)	3 of 50 (6%)	3 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Non-valvular Atrial Fibrillation

Active, not recruiting
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Active, not recruiting
CHAMPION-AF Clinical Trial
Atrial Fibrillation, Stroke
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
Non-valvular Atrial Fibrillation (AF)
Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chan Chin Pang Gary principal investigator

Prince of Wales Hospital, Shatin, Hong Kong

Fung Chi Yan Raymond principal investigator

Princess Margaret Hospital, Canada

Tsui Kin Lam principal investigator

Pamela Youde Nethersole Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-valvular Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint (time frame: First Follow-up (30 ~ 100 days);). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04096963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.