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Assessing the Safety and Efficacy of the LAmbre™ Plus Device

NCT06465706 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1826

Last updated 2024-08-23

No results posted yet for this study

Summary

Randomized controlled trial assessing the safety and efficacy of the LAmbre Plus LAA Closure System to rescue the risk of thromboembolism in patients with non-valvular AF.

Conditions

Interventions

DEVICE

LAmbre investigational device

Randomized 1:1 to either experimental group or control group.

Sponsors & Collaborators

  • Kansas City Heart Rhythm Research Foundation

    lead OTHER

Principal Investigators

  • Dhanunjaya Lakkireddy, MD · KCCARF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2029-10-01
Completion
2030-01-31
FDA Device
Yes

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Entities

Diseases

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 NCT06465706 on ClinicalTrials.gov