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I Can sEe Left Atrial Appendage (ICELAA) Clinical Study

NCT04196335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-18

No results posted yet for this study

Summary

The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.

Conditions

  • Efficacy, Self
  • Safety Issues

Interventions

DEVICE

intra-procedural intracardiac echocardiography

use of intra-procedural intracardiac echocardiography during Watchman FLX devices

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jens Erik Nielsen-Kudsk, MD · Aarhus University Hospital Skejby

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-09-24
Completion
2021-09-24

Countries

  • Denmark
  • Italy
  • Spain
  • United Kingdom

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 NCT04196335 on ClinicalTrials.gov