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

Aortic Stenosis Clinical Trial

— LAA-CLOSURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321137
• Other study ID #: UTurku
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: University of Turku
• Contact: Tuija Vasankari, RN
• Phone: +35823130900
• Email: tuija.vasankari[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1040
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Procedure:
• Surgical closure of left atrial appendage
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 appendage
aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Turku University Hospital	Turku
Netherlands	St Antonius Hospital	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
University of Turku	Helsinki University Central Hospital, Kuopio University Hospital, Landspitali University Hospital, St. Antonius Hospital

Countries where clinical trial is conducted

Finland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of stroke, systemic embolism and cardiovascular mortality		5 years
Secondary	stroke/systemic embolism		5 years
Secondary	cardiovascular mortality		5 years
Secondary	Net adverse events (primary endpoint and major bleeding)		5 years
Secondary	Hospitalization for decompensated heart failure		5 years
Secondary	Major bleeding (BARC 3a, b, c or 5)		5 years
Secondary	Any bleeding (BARC 1, 2 3a, b, c or 5)		5 years
Secondary	Surgery related bleeding (BARC 4)		5 years
Secondary	Stroke	30D Post-op thromboembolism	30 days postoperatively
Secondary	A composite outcome of any of the following: stroke, systemic embolism and cardiovascular mortality	A composite outcome of stroke, systemic embolism and cardiovascular mortality	30 days postoperatively

External Links

•   Published trial protocol