Trial Outcomes & Findings for Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong (NCT NCT04096963)
NCT ID: NCT04096963
Last Updated: 2024-08-12
Results Overview
The occurrence of non-effective LAA closure defined as any peri-device flow \> 5mm demonstrated by TEE/CT/MRI at First Follow-up.
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
First Follow-up (30 ~ 100 days);
Results posted on
2024-08-12
Participant Flow
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.
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.
Participant milestones
| Measure |
The Subjects Who Complete the Study
Subjects who sign informed consent, meets eligibility criteria and successfully implanted with the WATCHMAN FLX device and complete the study.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
The Subjects With No-valvular Atrial Fibrillation Who Implant the WATCHMAN FLX LAAC.
n=50 Participants
Subjects who meet the eligibility criteria, have signed and dated the Informed Consent Form and actually undergo a WATCHMAN FLX implant procedure.
|
|---|---|
|
Age, Customized
Age analysis result
|
75 years
STANDARD_DEVIATION 7.7 • n=50 Participants
|
|
Sex/Gender, Customized
Female participants number
|
17 participants
n=50 Participants
|
|
Sex/Gender, Customized
Male participants number
|
33 participants
n=50 Participants
|
|
Region of Enrollment
Hong Kong
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: First Follow-up (30 ~ 100 days);Population: A total of 46 participants completed the first follow up and belong to PPS set.
The occurrence of non-effective LAA closure defined as any peri-device flow \> 5mm demonstrated by TEE/CT/MRI at First Follow-up.
Outcome measures
| Measure |
The Participant Who is PPS Set.
n=46 Participants
The participant with a completed first follow-up visit is PPS set.
|
The Participant Who is ITT Set
The subject who enrolled to study.
|
|---|---|---|
|
Primary Effectiveness Endpoint
|
0 percentage of occurence
Interval 0.0 to 7.7
|
—
|
PRIMARY outcome
Timeframe: First Follow-up (30-100 days)Population: T
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.
Outcome measures
| Measure |
The Participant Who is PPS Set.
n=50 Participants
The participant with a completed first follow-up visit is PPS set.
|
The Participant Who is ITT Set
The subject who enrolled to study.
|
|---|---|---|
|
Primary Safety Endpoint
|
2.0 percentage of occurence
Interval 0.1 to 10.6
|
—
|
SECONDARY outcome
Timeframe: 12-Month Follow-up (365 ± 30 days)Population: A total of 46 participants belong to PPS set and 50 participants belong to ITT set.
The occurrence of ischemic stroke or systemic embolism at 12 months from the time of implant.
Outcome measures
| Measure |
The Participant Who is PPS Set.
n=46 Participants
The participant with a completed first follow-up visit is PPS set.
|
The Participant Who is ITT Set
n=50 Participants
The subject who enrolled to study.
|
|---|---|---|
|
Secondary Endpoint
|
0 participants
|
1 participants
|
Adverse Events
The Subjects Who Are Attempted or Implanted the WATCHMAN FLX LAAC
Serious events: 23 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
The Subjects Who Are Attempted or Implanted the WATCHMAN FLX LAAC
n=50 participants at risk
The subjects with no-valvular atrial fibrillation who are attempted or implanted the WATCHMAN FLX Left Atrial Appendage Closure (LAAC).
|
|---|---|
|
Nervous system disorders
Intracranial haemorrhage
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Infections and infestations
urinary tract infection
|
4.0%
2/50 • Number of events 2 • 0-12months post LAAC.
|
|
Infections and infestations
Pheumonia
|
6.0%
3/50 • Number of events 3 • 0-12months post LAAC.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.0%
3/50 • Number of events 3 • 0-12months post LAAC.
|
|
Nervous system disorders
Convulsion (Facial & Limb Twitching)
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
General disorders
General weakness
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Musculoskeletal and connective tissue disorders
Low back Pain
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Nervous system disorders
Ischemic Stroke
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Number of events 5 • 0-12months post LAAC.
|
|
Cardiac disorders
Pericardial Effusion
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Cardiac disorders
Fast Atrial Fibrillation
|
4.0%
2/50 • Number of events 2 • 0-12months post LAAC.
|
|
General disorders
Pyrexia
|
4.0%
2/50 • Number of events 2 • 0-12months post LAAC.
|
|
Nervous system disorders
Right leg involuntary movement
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Infections and infestations
Eseherichia coli septicaemia
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.0%
2/50 • Number of events 2 • 0-12months post LAAC.
|
|
Renal and urinary disorders
Malignant Urethral tumor
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Renal and urinary disorders
Haematuria
|
4.0%
2/50 • Number of events 2 • 0-12months post LAAC.
|
|
General disorders
Right groin wound oozing, postoperative
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Gastrointestinal disorders
Diverticulosis of colon
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Cardiac disorders
Acute decompensated heart failure (ADHF)
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
General disorders
Bleeding from the HD Catheter Site
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Cardiac disorders
Cardiac Chest Pain
|
2.0%
1/50 • Number of events 2 • 0-12months post LAAC.
|
|
Gastrointestinal disorders
Chronic Diarrhea
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Injury, poisoning and procedural complications
Collapse of lumbar vertebra
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
General disorders
fever
|
4.0%
2/50 • Number of events 2 • 0-12months post LAAC.
|
|
Cardiac disorders
Heart Failure
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Vascular disorders
Hypertension
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Nervous system disorders
INTRACEREBRAL HEMORRHAGE (ICH)
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Gastrointestinal disorders
Irreducible Left Inguinoscrotal Hernia
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Cardiac disorders
Ischaemic Heart Disease
|
2.0%
1/50 • Number of events 5 • 0-12months post LAAC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant rectal poylp
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parotid Tumour
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Reproductive system and breast disorders
Postmenopausal bleeding
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
General disorders
right leg swelling
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Nervous system disorders
ncope
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Nervous system disorders
Todd's paralysis
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Injury, poisoning and procedural complications
Wound Hematoma
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
Other adverse events
| Measure |
The Subjects Who Are Attempted or Implanted the WATCHMAN FLX LAAC
n=50 participants at risk
The subjects with no-valvular atrial fibrillation who are attempted or implanted the WATCHMAN FLX Left Atrial Appendage Closure (LAAC).
|
|---|---|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Immune system disorders
Drug Allergy
|
2.0%
1/50 • Number of events 2 • 0-12months post LAAC.
|
|
Injury, poisoning and procedural complications
Abrasion wound (Shaving)
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
General disorders
chest pain of unknown etiology
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Infections and infestations
COVID-19 infection
|
4.0%
2/50 • Number of events 2 • 0-12months post LAAC.
|
|
Cardiac disorders
Ischaemic Heart Disease
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Vascular disorders
Thrombus
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Infections and infestations
Tuberculosis of Lung
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Gastrointestinal disorders
Chronic Gastric Ulcer
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Eye disorders
Chalazion
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
|
Injury, poisoning and procedural complications
Sprain foot
|
2.0%
1/50 • Number of events 1 • 0-12months post LAAC.
|
Additional Information
Associate Clinical Trial Manager
Boston Scientific Corperation
Phone: +861085742971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place