Non-valvular Atrial Fibrillation
Conditions
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.
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.
Interventions
DEVICEThe WATCHMAN FLX Delivery System
WATCHMAN FLX Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients who are eligible for a WATCHMAN FLX device according to current international and local guidelines (and future revisions) and per physician discretion; 2. 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; 3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion criteria
1. 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. 2. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); 3. The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | 12-Month Follow-up (365 ± 30 days) | The occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant. |
Countries
China
Participant flow
Recruitment details
WATCHMAN FLX HK study completed FPI on 19 Jun 2020, and completed LPI on 8 Oct 2021, took almost 16 months to complete recruiting 50 patients. There are 50 subjects enrolled in study.
Pre-assignment details
Subjects who meet the eligibility criteria, have signed and dated the Informed Consent Form and actually undergo a WATCHMAN FLX implant procedure are considered enrolled in the study. Baseline data from subjects who meet the eligibility criteria, have signed and dated the Informed Consent Form but do not eventually undergo a WATCHMAN FLX implant procedure are collected for epidemiological reasons, to better characterize the population.
Participants by arm
| Arm | Count |
|---|---|
| The Subjects With No-valvular Atrial Fibrillation Who Implant the WATCHMAN FLX LAAC. Subjects who meet the eligibility criteria, have signed and dated the Informed Consent Form and actually undergo a WATCHMAN FLX implant procedure. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | The Subjects With No-valvular Atrial Fibrillation Who Implant the WATCHMAN FLX LAAC. | — |
|---|---|---|
| Age, Customized Age analysis result | 75 years STANDARD_DEVIATION 7.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Hong Kong | 50 participants | — |
| Sex/Gender, Customized Female participants number | 17 participants | — |
| Sex/Gender, Customized Male participants number | 33 participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 50 |
| other Total, other adverse events | 3 / 50 |
| serious Total, serious adverse events | 23 / 50 |
Outcome results
Primary
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.
Time frame: First Follow-up (30 ~ 100 days);
Population: A total of 46 participants completed the first follow up and belong to PPS set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The Participant Who is PPS Set. | Primary Effectiveness Endpoint | 0 percentage of occurence |
Primary
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.
Time frame: First Follow-up (30-100 days)
Population: T
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The Participant Who is PPS Set. | Primary Safety Endpoint | 2.0 percentage of occurence |
Secondary
Secondary Endpoint
The occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant.
Time frame: 12-Month Follow-up (365 ± 30 days)
Population: A total of 46 participants belong to PPS set and 50 participants belong to ITT set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The Participant Who is PPS Set. | Secondary Endpoint | 0 participants |
| The Participant Who is ITT Set | Secondary Endpoint | 1 participants |