Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery

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Brief Title

Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery

Official Title

A Randomized Prospective Multicenter Trial for Stroke Prevention by Surgical Occlusion of the Left Atrial Appendage in Patients Undergoing Aortic Bioprosthetic Surgery

Brief Summary

      The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical
      closure of LAA in patients undergoing aortic valve replacement. This randomized, prospective,
      open-label international multicenter trial will enroll 1040 patients undergoing aortic valve
      replacement with CHA2DS2-VASC score ≥2 but without an indication for anticoagulation at the
      time of enrollment. Patients will be randomized in 1:1 fashion to standard therapy + surgical
      closure of LAA vs. standard therapy alone. The duration of the study is five years (plus
      additional 10 years).

Detailed Description

      Previous studies have concluded that ≥90% of AF related left atrial thrombi are located in
      the left atrial appendage (LAA). Surgical closure of LAA can be performed using ligation,
      stapler or other devices designed for this purpose during cardiac surgery. However, current
      evidence for surgical closure of LAA is scarce and no large scale randomized prospective
      clinical trials addressing this issue have been published. American College of Cardiology
      (ACC)/ American Heart Association (AHA) guidelines state that LAA exclusion should be
      considered in patients with recurrent and persistent AF who remain symptomatic with heart
      rate control and where antiarrhythmic medication is not tolerated or no longer effective.
      Current European Association of Cardiothoracic Surgery (EACTS) guidelines conclude that there
      is no proven benefit of surgical LAA exclusion in terms of stroke reduction or mortality
      benefit (level of evidence 2a B), and if exclusion is contemplated, devices designed for
      appendage exclusion should be used rather than a cut-and-sew or stapling technique. These
      guidelines are based on small poorly designed descriptive trials and only one small
      randomized trial.

      LAA-CLOSURE trial aims to assess efficacy and safety of prophylactic surgical closure of LAA
      in patients undergoing aortic valve replacement.

Study Type

Interventional

Primary Outcome

A composite of stroke, systemic embolism and cardiovascular mortality

Secondary Outcome

 stroke/systemic embolism

Condition

Aortic Stenosis

Intervention

Surgical closure of left atrial appendage

Study Arms / Comparison Groups

 BioAVR with surgical closure of LAA
Description:  Aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease including surgical closure of left atrial appendage

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

1040

Start Date

November 2014

Completion Date

December 2027

Primary Completion Date

December 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Patients undergoing aortic valve replacement (+/- coronary bypass AND/OR mitral valve
             surgery) according to clinical indications (ESC guidelines for the management of
             valvular heart disease)

          2. Age ≥18 years

          3. No indication for long term anticoagulation at the time of enrollment.

          4. Patients with CHADS-VASC score ≥2

          5. Patient is willing to comply with specified follow-up evaluations

          6. Patient or legally authorized representative has been informed of the nature of the
             study, agrees to its provisions and has been provided written informed consent,
             approved by the appropriate Medical Ethics committee or Institutional Review Board.

        Exclusion Criteria:

          -  Age < 18 years

          -  Expected survival < 1 year

          -  Chronic atrial fibrillation

          -  Indication for long term anticoagulation therapy before the index procedure

          -  Mechanical valve implantation previously or at the index procedure

          -  Any significant medical condition, which in the Investigator's opinion may interfere
             with the patient's optimal participation in the study.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tuomas Kiviniemi, MD, PhD, +35823130900, [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations

NCT ID

NCT02321137

Organization ID

UTurku

Responsible Party

Principal Investigator

Study Sponsor

University of Turku

Collaborators

 Helsinki University Central Hospital

Study Sponsor

Tuomas Kiviniemi, MD, PhD, Principal Investigator, Turku University Hospital, Turku, Finland

Verification Date

May 2017