NCT02321137

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).

Trial Health

78
On Track

Trial Health Score

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

Enrollment
1,040

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

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 Progress77%
Nov 2014Dec 2029

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Expected
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

10.5 years

First QC Date

December 11, 2014

Last Update Submit

June 5, 2025

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • A composite of stroke, systemic embolism and cardiovascular mortality

    5 years

Secondary Outcomes (9)

  • stroke/systemic embolism

    5 years

  • cardiovascular mortality

    5 years

  • Net adverse events (primary endpoint and major bleeding)

    5 years

  • Hospitalization for decompensated heart failure

    5 years

  • Major bleeding (BARC 3a, b, c or 5)

    5 years

  • +4 more secondary outcomes

Study Arms (2)

BioAVR with surgical closure of LAA

ACTIVE COMPARATOR

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

Procedure: Surgical closure of left atrial appendage

BioAVR alone

PLACEBO COMPARATOR

Aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.

Procedure: No closure of left atrial appendage

Interventions

Surgical closure of left atrial appendagePROCEDURE

aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease. The operation as well as the pre and post-operative care will be performed according to local surgical policies.

BioAVR with surgical closure of LAA
No closure of left atrial appendagePROCEDURE

aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.

BioAVR alone

Eligibility Criteria

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

You may qualify if:

  • 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)
  • Age ≥18 years
  • No indication for long term anticoagulation at the time of enrollment.
  • Patients with CHADS-VASC score ≥2
  • Patient is willing to comply with specified follow-up evaluations
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Hospital

Helsinki, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

St Antonius Hospital

Utrecht, Netherlands

Location

Related Links

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Tuomas Kiviniemi, MD, PhD

    Turku University Hospital, Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 22, 2014

Study Start

November 1, 2014

Primary Completion

April 30, 2025

Study Completion (Estimated)

December 1, 2029

Last Updated

June 10, 2025

Record last verified: 2025-06

Locations

NL(1)FI(3)