N/A
N=160
Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry
Left Atrail Appendage Closure: Peri-device Leaks
Bottom Line
View on ClinicalTrials.gov: NCT05131308 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Size of PDL After Leak Closure Procedure — 0; 0; 0; 64 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kansas City Heart Rhythm Research Foundation
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Size of PDL After Leak Closure Procedure |
0; 0; 0; 64; 36; 60 | — |
| SECONDARY Periprocedural Complications Occurring From Postoperative Day 0 - Day 7 |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Delayed Procedure-related Complications at 1 Year Follow-up |
0; 0; 0; 0; 0; 0 | — |
Summary
Closure of peri-device leaks (PDL) after incomplete LAAC have shown early feasibility, however no comparison study of all the leak closure modalities exists. Therefore, this is an attempt to report the first 3-way observational comparison study to date, with results in 160 total patients in 3 arms including detachable embolization coils, vascular plugs/septal occluders and Radiofrequency ablation.
Eligibility Criteria
Inclusion Criteria
- Patients at risk for stroke or thromboembolism that demonstrated any degree of the significant leak on follow up TEE imaging at least 4-6 weeks following either epicardial, endocardial, or surgical LAAC
- Patients undergoing any form of eccentric or centric/central leak closure with available modalities (detachable embolization coils, vascular plus/septal/ASD occluders, or RF Ablation). Criteria for this was made based on the judgement of the operator, with no specific cutoffs for leak size, follow-up time from LAAC to leak closure, etc)
- Age greater than 18 years
Exclusion Criteria
- Patients not undergoing leak closure after incomplete LAAC
- Patients unable to complete 45 day follow-up imaging for reevaluation of LAA leak
- Patients unable to consent
Data sourced from ClinicalTrials.gov (NCT05131308). 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.