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

March 2, 2019 updated by: Piotr Suwalski, PhD, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive patients with atrial fibrillation assigned for the totally thoracoscopic left atrial appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The registry has no limit of the number of patient included. Patients will be followed up with transoesophageal echocardiography at 6-12 months to assess the durability of left atrial appendage (LAA) oclusion and collect the informations about possible adverse events.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 02-507
        • Recruiting
        • Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The registry will include all patients with atrial fibrillation with high risk of thromboembolic complications - CHA2DS2-VASc Score >2 and HASBLED score of => 2 refered to primary or secondary stroke prevention who do not require open chest surgery for other reasons.

Description

Inclusion Criteria:

  • Age >18 years
  • Lone atrial fibrillation
  • Previous stroke or systemic thromboembolic complications
  • High risk of thromboembolic complications assessed with CHA2DS2-VASc Score >2
  • High bleeding risk assessed with HASBLED score => 2.
  • Contraindications to oral anticoagulation
  • Complications of the oral anticoagulation
  • Acceptable surgical candidate, including use of general anaesthesia

Exclusion Criteria:

  • Patient refusal
  • Significant valve disease or coronary multi-vessel artery lesions requiring surgery
  • Stroke/cerebrovascular accident (CVA) within previous 30 days
  • Critical preoperative state

Intra-Operative Exclusion Criteria

  • Presence of thrombus in the left atrium or LAA as documented on intra-operative transesophageal echocardiography
  • LAA tissue with significant adhesions (as evaluated by the surgeon) carries AtriClip placement overly risky.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Included
The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention.
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.
Other Names:
  • AtriClip LAA Exclusion System and Delivery System (LAAØ)
  • AtriClip LAA Exclusion System and Delivery System (PRO1)
  • AtriClip LAA Exclusion System and Delivery System (PRO2)
Drug: Oral anticoagulation therapy
Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complications
Time Frame: First 5 postoperative days
Number of perioperative complications associated with AtriClip placement
First 5 postoperative days
Intraoperative success of exclusion of LAA.
Time Frame: Intraoperatively
Successful exclusion of LAA is defined as no communication between LAA and LA and < 5 mm LAA remnant measured by intraoperative transesophageal echo with Doppler.
Intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: 5 years
Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke.
5 years
Pulmonary complications.
Time Frame: Up to 30 days post operation
Number of participants requiring prolonged mechanical ventilation postoperatively
Up to 30 days post operation
Any complications connected with surgical intervention
Time Frame: Up to 30 days post operation
Rate of bleeding requiring transfusion or re-operation, phrenic nerve palsy, oedema requiring intervention, wound infection, abscess in pleura
Up to 30 days post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2015

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

February 9, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 2, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ThR-LAAO-PL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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