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NCT05131308 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Kansas City Heart Rhythm Research Foundation.

Completed
Registry status
160
Enrollment target

NCT05131308: Completed study, sponsored by Kansas City Heart Rhythm Research Foundation.

NCT05131308 is a clinical trial that has completed, run by Kansas City Heart Rhythm Research Foundation. The registered enrollment target is 160 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05131308 has completed, sponsored by Kansas City Heart Rhythm Research Foundation.

COMPLETED
Registry status
160 participants
Enrollment target

Study 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.

Primary Outcome

Size of leak in mm on TEE after leak closure procedure, immediately at the end of the procedure and at 1 year follow-up

Interventions

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

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2015-01-11
Est. Completion 2021-06-08

What the finished NCT05131308 record still lists

NCT05131308 is an observational study that tracks outcomes without assigning an intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA is the first listed.

NCT05131308 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05131308 about?

NCT05131308 is a clinical study titled "Multimodality Evaluation of LAA Leaks Arising After Incomplete LAAC: Insights From the LAA-Leak Registry". 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 i...

What is the current status of trial NCT05131308?

This trial is currently completed. The enrollment target is 160 participants. The study started on 2015-01-11. Estimated completion is 2021-06-08.

What interventions are being tested in trial NCT05131308?

The interventions under investigation include: leak closure with either detachable embolization coils, vascular plugs/CSO, or RFA (OTHER).

Who is sponsoring clinical trial NCT05131308?

This trial is sponsored by Kansas City Heart Rhythm Research Foundation, which has 22 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05131308, the US trial registry maintained by the National Library of Medicine. NCT05131308 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.