N/A
N=156
VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
Left Atrial Appendage Absent
Bottom Line
View on ClinicalTrials.gov: NCT05101993 ↗Enrolled (actual)
156
Serious AEs
49.0%
Results posted
Jun 2025
Primary outcome: Primary: Primary Performance Endpoint — 151 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AtriClip (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Performance Endpoint |
151 | — |
| PRIMARY Primary Safety Endpoint |
— | <0.0001 sig |
| SECONDARY Performance |
135 | — |
| SECONDARY Long-term Thromboembolic Events |
— | — |
| SECONDARY Device and Procedure Long-term Safety |
5 | — |
Summary
Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures.
Eligibility Criteria
Inclusion Criteria
- Subject is greater than or equal to 18 years of age.
- Subject who received the AtriClip FLEX-V or PRO•V implant during a non-emergent cardiac surgical procedure
- Subject is willing and able to provide written informed consent
- Subject is willing and able to return for scheduled follow-up visit and imaging (CTA or TEE)
Exclusion Criteria
- Inability, unwillingness, or contraindication to undergo TEE or CTA imaging
- Subjects who are pregnant or breast feeding
- Subjects with active COVID-19 infection
Data sourced from ClinicalTrials.gov (NCT05101993). 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.