Trial Outcomes & Findings for Watchman FLX Pro CT Pilot Study (NCT NCT05567172)
NCT ID: NCT05567172
Last Updated: 2025-12-09
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
43 participants
Primary outcome timeframe
14 days to 3 months post implant
Results posted on
2025-12-09
Participant Flow
Participant milestones
| Measure |
Device Arm
Watchman FLX Pro: Left atrial appendage closure device
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Device Arm
Watchman FLX Pro: Left atrial appendage closure device
|
|---|---|
|
Overall Study
Death
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Device Arm
n=43 Participants
Watchman FLX Pro Device Implantation
|
|---|---|
|
Age, Continuous
|
74.6 years
STANDARD_DEVIATION 7.8 • n=43 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=43 Participants
|
|
Region of Enrollment
Denmark
|
43 Participants
n=43 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=43 Participants
Watchman FLX Pro 14 days post device implantation
|
45 Days
n=39 Participants
Watchman FLX Pro 45 days post device implantation
|
3 Months
n=42 Participants
Watchman FLX Pro 3 months post device implantation
|
|---|---|---|---|
|
Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device
|
3 Participants
|
5 Participants
|
5 Participants
|
Adverse Events
Device Arm
Serious events: 23 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Device Arm
n=43 participants at risk
Watchman FLX Pro device implantation: Left atrial appendage closure using the Watchman FLX Pro device
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.7%
2/43 • Number of events 2 • 12 Months
Site Reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Vascular disorders
Embolism arterial
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Vascular disorders
Haematoma
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Vascular disorders
Hypertension
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
4.7%
2/43 • Number of events 2 • 12 Months
Site Reported
|
|
Cardiac disorders
Atrial Fibrillation
|
9.3%
4/43 • Number of events 4 • 12 Months
Site Reported
|
|
Cardiac disorders
Cardiac Failure
|
4.7%
2/43 • Number of events 2 • 12 Months
Site Reported
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
General disorders
Device related thrombosis
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Infections and infestations
Covid-19
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Infections and infestations
Influenza
|
2.3%
1/43 • Number of events 2 • 12 Months
Site Reported
|
|
Infections and infestations
Pneumonia
|
7.0%
3/43 • Number of events 3 • 12 Months
Site Reported
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Infections and infestations
Urinary tract infection
|
7.0%
3/43 • Number of events 3 • 12 Months
Site Reported
|
|
Infections and infestations
Urosepsis
|
2.3%
1/43 • Number of events 2 • 12 Months
Site Reported
|
|
Injury, poisoning and procedural complications
Concussion
|
4.7%
2/43 • Number of events 2 • 12 Months
Site Reported
|
|
Injury, poisoning and procedural complications
Eye injury
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Nervous system disorders
Cerebrovascular accident
|
4.7%
2/43 • Number of events 2 • 12 Months
Site Reported
|
|
Nervous system disorders
Epilepsy
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.3%
1/43 • Number of events 4 • 12 Months
Site Reported
|
|
Product Issues
Device leakage
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
Other adverse events
| Measure |
Device Arm
n=43 participants at risk
Watchman FLX Pro device implantation: Left atrial appendage closure using the Watchman FLX Pro device
|
|---|---|
|
Gastrointestinal disorders
GI bleeding
|
2.3%
1/43 • Number of events 2 • 12 Months
Site Reported
|
|
General disorders
Catheter site bleeding
|
7.0%
3/43 • Number of events 3 • 12 Months
Site Reported
|
|
General disorders
Device related thrombosis
|
4.7%
2/43 • Number of events 2 • 12 Months
Site Reported
|
|
Product Issues
Device leakage
|
4.7%
2/43 • Number of events 2 • 12 Months
Site Reported
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
|
Vascular disorders
Groin hematoma
|
2.3%
1/43 • Number of events 1 • 12 Months
Site Reported
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place