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Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

NCT05131308 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Left Atrail Appendage Closure: Peri-device Leaks

Interventions

OTHER

leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA

All patients were evaluated and followed with imaging, and per investigators' respective clinical judgement, then proceeded to have an intervention for leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA.

Sponsors & Collaborators

  • Kansas City Heart Rhythm Research Foundation

    lead OTHER

Principal Investigators

  • Dhanunjaya Lakkireddy · Kansas City Heart Rhythm Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-11
Primary Completion
2021-03-14
Completion
2021-06-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131308 on ClinicalTrials.gov