NCT03838341

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

5.6 years

First QC Date

January 27, 2019

Last Update Submit

March 2, 2019

Conditions

Stroke PreventionAtrial FibrillationSafety Issues

Keywords

Stroke preventionAtrial fibrillationTotally thoracoscopicLAAOAtriClip®

Outcome Measures

Primary Outcomes (2)

  • Perioperative complications

    Number of perioperative complications associated with AtriClip placement

    First 5 postoperative days

  • Intraoperative success of exclusion of LAA.

    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 Outcomes (3)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    5 years

  • Pulmonary complications.

    Up to 30 days post operation

  • Any complications connected with surgical intervention

    Up to 30 days post operation

Study Arms (1)

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 SystemDrug: Oral anticoagulation therapy

Interventions

AtriClip™ LAA Exclusion SystemDEVICE

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.

Also known as: AtriClip LAA Exclusion System and Delivery System (LAAØ), AtriClip LAA Exclusion System and Delivery System (PRO1), AtriClip LAA Exclusion System and Delivery System (PRO2)
Included
Oral anticoagulation therapyDRUG

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

Included

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw

Warsaw, 02-507, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Piotr Suwalski, PhD

    Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Suwalski, PhD

CONTACT

+48225081269suwalski.piotr@gmail.com

Anna Witkowska, MD

CONTACT

+48662076716vera@rallywitkowscy.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Philosophy

Study Record Dates

First Submitted

January 27, 2019

First Posted

February 12, 2019

Study Start

June 8, 2015

Primary Completion

December 31, 2020

Study Completion

January 1, 2025

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

PL(1)