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Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.

NCT03838341 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-03-05

No results posted yet for this study

Summary

Polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation.

Conditions

Interventions

DEVICE

AtriClip™ LAA Exclusion System

The left atrial appendage is closed from the epicardial side of the heart. Operative access is totally thoracoscopic. The designed and dedicated clip - AtriClip® (AtriCure, Ohio, USA) is introduced to the left pleura through thoracoscopic port.

DRUG

Oral anticoagulation therapy

Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.

Sponsors & Collaborators

  • Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Piotr Suwalski, PhD · Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-08
Primary Completion
2020-12-31
Completion
2025-01-01
FDA Device
Yes

Countries

  • Poland

Study Locations

More Related Trials

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 NCT03838341 on ClinicalTrials.gov