Aortic StenosisLAA-CLOSURENCT02321137
Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery
A study testing Surgical closure of left atrial appendage and No closure of left atrial appendage in people with Aortic Stenosis, run by University of Turku at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Surgical closure of left atrial appendage and No closure of left atrial appendage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,040 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2014to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Finland3 sites
Helsinki University Hospital
Helsinki
Kuopio University Hospital
Kuopio
Turku University Hospital
Turku, 20520
About this study
Official title: A Randomized Prospective Multicenter Trial for Stroke Prevention by Surgical Occlusion of the Left Atrial Appendage in Patients Undergoing Aortic Bioprosthetic Surgery
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).
Read the 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.
- Conditions
- Aortic Stenosis
- Being tested
- Surgical closure of left atrial appendage, No closure of left atrial appendage
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical closure of left atrial appendageProcedure or surgery
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.
No closure of left atrial appendageProcedure or surgery
aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: No closure of left atrial appendage |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of stroke, systemic embolism and cardiovascular mortality
Measured: 5 years
Secondary outcomes (9)
stroke/systemic embolism
Measured: 5 years
cardiovascular mortality
Measured: 5 years
Net adverse events (primary endpoint and major bleeding)
Measured: 5 years
Hospitalization for decompensated heart failure
Measured: 5 years
Major bleeding (BARC 3a, b, c or 5)
Measured: 5 years
Any bleeding (BARC 1, 2 3a, b, c or 5)
Measured: 5 years
Surgery related bleeding (BARC 4)
Measured: 5 years
Stroke
30D Post-op thromboembolism
Measured: 30 days postoperatively
A composite outcome of any of the following: stroke, systemic embolism and cardiovascular mortality
A composite outcome of stroke, systemic embolism and cardiovascular mortality
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startNov 2014
- Primary completion30 Apr 2025
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, St. Antonius Hospital, Landspitali University Hospital
- Responsible party
- Principal investigator, Tuomas Kiviniemi, University of Turku
- Investigators
- Tuomas Kiviniemi, MD, PhD, Principal investigator, Turku University Hospital, Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321137
- Sponsor's protocol ID
- UTurku
- Acronym
- LAA-CLOSURE
- Status last verified
- Jun 2025
- First submitted
- 11 Dec 2014
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kiviniemi T, Halfwerk F, Bustamante Munguira J, Zindovic I, Malmberg M, Olsson C, Perrotta S, van Schaagen F, Suwalski P, Hartikainen J, Hanke T, Reyes Copa G, Speekenbrink RGH, Bustamante E, Erixon C, Gunn J, Bjurbom M, Jeppsson A, Oei F, Wietsma NE, Dahlberg S, Lip G, Lehto J, Vasankari T, Airaksinen J, van Putte B; LAA-CLOSURE Investigators *. Prophylactic Surgical Left Atrial Appendage Closure in Bioprosthetic Aortic Valve Replacement: Short-Term Outcomes of Randomized Controlled LAA-CLOSURE Trial. J Am Heart Assoc. 2026 Aug 20:e046654. doi: 10.1161/JAHA.125.046654. Online ahead of print.
PubMed 42622223
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Multicenter Trial for Stroke Prevention by Surgical Occlusion of the Left Atrial Appendage in Patients Undergoing Aortic Bioprosthetic Surgery
- ClinicalTrials.gov ID
- NCT02321137
- Acronym / sponsor ID
- LAA-CLOSURE / UTurku
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, St. Antonius Hospital, Landspitali University Hospital
- Study start
- Nov 2014
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioAVR with surgical closure of LAA | Active comparator | Procedure: Surgical closure of left atrial appendageAortic 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 |
| BioAVR alone | Placebo comparator | Procedure: No closure of left atrial appendageAortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical closure of left atrial appendageaortic 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. | Procedure or surgery | BioAVR with surgical closure of LAA |
| No closure of left atrial appendageaortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease. | Procedure or surgery | BioAVR alone |
Primary outcome
A composite of stroke, systemic embolism and cardiovascular mortality
Time frame: 5 years
9 secondary outcomes
stroke/systemic embolism
Time frame: 5 years
cardiovascular mortality
Time frame: 5 years
Net adverse events (primary endpoint and major bleeding)
Time frame: 5 years
Hospitalization for decompensated heart failure
Time frame: 5 years
Major bleeding (BARC 3a, b, c or 5)
Time frame: 5 years
Any bleeding (BARC 1, 2 3a, b, c or 5)
Time frame: 5 years
Surgery related bleeding (BARC 4)
Time frame: 5 years
Stroke
Time frame: 30 days postoperatively
A composite outcome of any of the following: stroke, systemic embolism and cardiovascular mortality
Time frame: 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 42622223Kiviniemi T, Halfwerk F, Bustamante Munguira J, Zindovic I, Malmberg M, Olsson C, Perrotta S, van Schaagen F, Suwalski P, Hartikainen J, Hanke T, Reyes Copa G, Speekenbrink RGH, Bustamante E, Erixon C, Gunn J, Bjurbom M, Jeppsson A, Oei F, Wietsma NE, Dahlberg S, Lip G, Lehto J, Vasankari T, Airaksinen J, van Putte B; LAA-CLOSURE Investigators *. Prophylactic Surgical Left Atrial Appendage Closure in Bioprosthetic Aortic Valve Replacement: Short-Term Outcomes of Randomized Controlled LAA-CLOSURE Trial. J Am Heart Assoc. 2026 Aug 20:e046654. doi: 10.1161/JAHA.125.046654. Online ahead of print.
- Published trial protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuomas Kiviniemi, MD, PhD principal investigator
Turku University Hospital, Turku, Finland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical closure of left atrial appendage and No closure of left atrial appendage in people with Aortic Stenosis, run by University of Turku at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of stroke, systemic embolism and cardiovascular mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02321137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.