Trial Outcomes & Findings for WATCHMAN FLX™ CT Study (NCT NCT05324371)
NCT ID: NCT05324371
Last Updated: 2025-07-01
Results Overview
Serial measurement of any HAT on the surface of the device at 14 days, 45 days and 3 months post implant as assessed by core lab using CT imaging
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
14 days to 3 months post implant
Results posted on
2025-07-01
Participant Flow
Participant milestones
| Measure |
Device Arm
WATCHMAN FLX™ device implantation
Watchman FLX Device: Left atrial appendage closure using the Watchman FLX device
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Device Arm
WATCHMAN FLX™ device implantation
Watchman FLX Device: Left atrial appendage closure using the Watchman FLX device
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Device Arm
n=25 Participants
WATCHMAN FLX Device Implantation
|
|---|---|
|
Age, Continuous
|
76.6 years
STANDARD_DEVIATION 7.2 • n=25 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=25 Participants
|
|
Region of Enrollment
Denmark
|
25 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 14 days to 3 months post implantSerial measurement of any HAT on the surface of the device at 14 days, 45 days and 3 months post implant as assessed by core lab using CT imaging
Outcome measures
| Measure |
14 Days
n=24 Participants
WATCHMAN FLX™ 14 days post device implantation
|
45 Days
n=23 Participants
WATCHMAN FLX™ 45 days post device implantation
|
3 Months
n=23 Participants
WATCHMAN FLX™ 3 months post device implantation
|
|---|---|---|---|
|
Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device
|
5 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Device Arm
Serious events: 10 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Device Arm
n=25 participants at risk
WATCHMAN FLX™ device implantation
Watchman FLX Device: Left atrial appendage closure using the Watchman FLX device
|
|---|---|
|
Cardiac disorders
Aortic Valve Incompetence
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Cardiac disorders
Atrial Fibrillation
|
4.0%
1/25 • Number of events 3 • 1 Year
Site Reported
|
|
Gastrointestinal disorders
Gastric Ulcer
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Infections and infestations
Pneumonia
|
12.0%
3/25 • Number of events 3 • 1 Year
Site Reported
|
|
Infections and infestations
Urosepsis
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Injury, poisoning and procedural complications
Graft Haemorrhage
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Nervous system disorders
Cerebral Haemorrhage
|
8.0%
2/25 • Number of events 2 • 1 Year
Site Reported
|
|
Renal and urinary disorders
Renal Failure
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
General disorders
Death
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
Other adverse events
| Measure |
Device Arm
n=25 participants at risk
WATCHMAN FLX™ device implantation
Watchman FLX Device: Left atrial appendage closure using the Watchman FLX device
|
|---|---|
|
General disorders
Device Related Thrombosis
|
8.0%
2/25 • Number of events 2 • 1 Year
Site Reported
|
|
General disorders
Catheter Site Haemorrhage
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
|
Nervous system disorders
Sedation
|
4.0%
1/25 • Number of events 1 • 1 Year
Site Reported
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place