N/A
Completed N=100
Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device
Source: ClinicalTrials.gov NCT05136417 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Dec 2024
Primary outcomePrimary: Successful Implantation of WATCHMAN FLX Device — 96 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Implantation of WATCHMAN FLX Device |
96 | — |
| PRIMARY Major Complications |
3 | — |
| SECONDARY Procedure Conversion to General Anesthesia |
— | — |
| SECONDARY Iatrogenic Atrial Septal Defect |
17 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05136417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.