Trial Outcomes & Findings for Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device (NCT NCT05136417)

NCT ID: NCT05136417

Last Updated: 2024-12-27

Results Overview

Number of participants with a successfully implanted WATCHMAN FLX device. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak \<5 mm) as assessed by a core lab interpretation of the transesophageal echocardiogram (TEE) 45 days post-implant.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 45 days post procedure
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) 100 patients undergoing left atrial appendage (LAA) closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) n=100 Participants 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Age, Continuous	77.0 years STANDARD_DEVIATION 8.1 • n=100 Participants
Sex: Female, Male Female	39 Participants n=100 Participants
Sex: Female, Male Male	61 Participants n=100 Participants
Region of Enrollment United States	100 participants n=100 Participants

PRIMARY outcome

Timeframe: 45 days post procedure

Number of participants with a successfully implanted WATCHMAN FLX device. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the transesophageal echocardiogram (TEE) 45 days post-implant.

Outcome measures

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) n=100 Participants 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Successful Implantation of WATCHMAN FLX Device	96 Participants

PRIMARY outcome

Timeframe: up to 7 days post procedure

Number of participants who experience major complications defined as major bleeding (intracranial bleeding, or bleeding requiring blood transfusion), pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death).

Outcome measures

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) n=100 Participants 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Major Complications	3 Participants

SECONDARY outcome

Timeframe: baseline

Number of participants who required conversion from moderate sedation to general anesthesia for implant procedure.

Outcome measures

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) n=100 Participants 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Procedure Conversion to General Anesthesia	0 Participants

SECONDARY outcome

Timeframe: 45 days post procedure

Number of participants with an iatrogenic atrial septal defect.

Outcome measures

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) n=100 Participants 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Iatrogenic Atrial Septal Defect	17 Participants

Adverse Events

Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) n=100 participants at risk 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Gastrointestinal disorders Gastrointestinal bleeding requiring transfusion	2.0% 2/100 • Number of events 2 • Adverse events were collected on each participant from enrollment to 45 days post procedure, for a total of approximately 60 days.
Injury, poisoning and procedural complications Procedural-related stroke	1.0% 1/100 • Number of events 1 • Adverse events were collected on each participant from enrollment to 45 days post procedure, for a total of approximately 60 days.

Other adverse events

Measure	Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) n=100 participants at risk 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. intra-procedural intracardiac echocardiography (ICE) probe: placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
General disorders Access site hematoma	5.0% 5/100 • Number of events 5 • Adverse events were collected on each participant from enrollment to 45 days post procedure, for a total of approximately 60 days.
General disorders Postoperative bleeding	3.0% 3/100 • Number of events 3 • Adverse events were collected on each participant from enrollment to 45 days post procedure, for a total of approximately 60 days.
Cardiac disorders Pericarditis	1.0% 1/100 • Number of events 1 • Adverse events were collected on each participant from enrollment to 45 days post procedure, for a total of approximately 60 days.
Cardiac disorders Myocardial infarction	1.0% 1/100 • Number of events 1 • Adverse events were collected on each participant from enrollment to 45 days post procedure, for a total of approximately 60 days.

Additional Information

Dr. Mohamad Alkhouli

Mayo Clinic

Phone: 507-255-2502

Email: Alkhouli.Mohamad@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place