CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
leak closure with either detachable embolization coils, vascular plugs/CSO, or RFAother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05131308
NCT05131308N/ACompleted
CompareCT.gov

Comparison of the Efficacy of Successful Leak Closure Between Available Leak Closure Methods for Clinically Relevant and Persisting Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry

Kansas City Heart Rhythm Research Foundation·observational·Posted Nov 23, 2021·Updated Sep 19, 2024

In Brief

An observational study evaluating leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA for Left Atrail Appendage Closure: Peri-device Leaks. Completed, enrolled 160 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLeft Atrail Appendage Closure: Peri-device Leaks
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 23, 2021
Enrollment StartJan 11, 2015
Primary CompletionMar 14, 2021
Study CompletionJun 8, 2021
TodayJul 1, 2026
Enrollment to primary: 6.2 yearsPosted 4.6 years ago

Interventions

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

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.