Left Atrial Appendage Occlusion
Conditions
Brief summary
The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.
Interventions
DEVICEintra-procedural intracardiac echocardiography (ICE) probe
placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patients is eligible to undergo WATCHMAN device implant procedure. * The patient is eligible for short term anticoagulation therapy. * Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s). * Ability to give informed consent for the procedure. * The patient is able and willing to undergo the procedure under moderate sedation. * The patient is able and willing to return for required 45-day transesophageal echocardiogram (TEE).
Exclusion criteria
* Patient has contraindication for short term anticoagulation. * The patient has history of a hypercoagulable state per medical record documentation. * Pregnancy or planning to get pregnant during the investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Implantation of WATCHMAN FLX Device | 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. |
| Major Complications | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Conversion to General Anesthesia | baseline | Number of participants who required conversion from moderate sedation to general anesthesia for implant procedure. |
| Iatrogenic Atrial Septal Defect | 45 days post procedure | Number of participants with an iatrogenic atrial septal defect. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) 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. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) | — |
|---|---|---|
| Age, Continuous | 77.0 years STANDARD_DEVIATION 8.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 100 participants | — |
| Sex: Female, Male Female | 39 Participants | — |
| Sex: Female, Male Male | 61 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 100 |
| other Total, other adverse events | 10 / 100 |
| serious Total, serious adverse events | 3 / 100 |
Outcome results
Primary
Major Complications
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).
Time frame: up to 7 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) | Major Complications | 3 Participants |
Primary
Successful Implantation of WATCHMAN FLX Device
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.
Time frame: 45 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) | Successful Implantation of WATCHMAN FLX Device | 96 Participants |
Secondary
Iatrogenic Atrial Septal Defect
Number of participants with an iatrogenic atrial septal defect.
Time frame: 45 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) | Iatrogenic Atrial Septal Defect | 17 Participants |
Secondary
Procedure Conversion to General Anesthesia
Number of participants who required conversion from moderate sedation to general anesthesia for implant procedure.
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Left Atrial Appendage (LAA) Occlusion With the WATCHMAN FLX Device Using (ICE) | Procedure Conversion to General Anesthesia | 0 Participants |