Left Atrial Appendage Closure by Surgery-2

NCT03724318 | Active Not Recruiting DMC

• 1 other identifier: H-17033253
• Study Type: interventional
• Target: 1,500
• Locations: 3 countries
• Sites: 4

Brief Summary

Atrial fibrillation is a heart rhythm disorder that often occurs after heart surgery. During atrial fibrillation blood cloths may form, predominantly in the left atrial appendage, a small sac in the wall of the left side of the heart. Some heart surgeons close this appendage to protect against stroke, particularly in patients with a history of atrial fibrillation, yet there is little evidence to support the efficacy and safety of this practice. We therefore conducted the Left Atrial Appendage Closure by Surgery (LAACS) study (2010-2016) were patients in whom the appendage was closed (by chance) suffered fewer brain damages that patients where it remained open. Although encouraging, these results were not only based on strokes, but also on scars without symptoms found in brain scans. The following LAACS-2 study will include a sufficient number of patients to determine whether future guidelines should advise to close systematically the left atrium appendage during a heart operation.

Conditions

Stroke, Ischemic; Atrial Fibrillation

Keywords

Left Atrium Appendage; Atrial Fibrillation; Stroke; Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Number of participants with Stroke occurrence including Transitory cerebral ischemia (TCI)

  Stroke is an acute episode of focal dysfunction of the brain, retina, or spinal cord lasting longer than 24 h, or of any duration if imaging (CT or MRI) or autopsy show focal infarction relevant to the symptoms. Transitory cerebral ischemia (TCI) is defined as above, but with symptoms lasting less than 24 h. Endpoints will be assigned by two independent neurologists, who are blinded to what procedure the patient undergo. In case of discrepancy, the events will be assigned by consensus.

  at least two years, until end of follow-up

Secondary Outcomes (3)

• Combined end-point of Stroke, TCI or Silent brain infarction

  at least two years, until end of follow-up

• Ischemic Stroke, including TCI

  at least two years, until end of follow-up

• Composite outcome of all-cause mortality and stroke (ischemic or hemorrhagic)

  at least two years, until end of follow-up

Other Outcomes (6)

• Safety outcome - Composite of peri- and postoperative complications

  30 days after surgery

• Safety outcome: Readmission or death due to bleeding

  30 days after surgery

• Safety outcome: Readmission or death due to heart injury

  30 days after surgery

Study Arms (2)

Closure

ACTIVE COMPARATOR

Patients randomized to the active Group will undergo closure of the left atrium appendage during Heart surgery by means of commercial clips

Procedure: closure of the left atrium appendage

Control

NO INTERVENTION

The left atrium appendage will remain open in patients randomized to the control group

Interventions

closure of the left atrium appendage PROCEDURE

closure of the left atrium appendage in addition to the planned Heart operation

Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for planned first-time heart surgery:
• Coronary artery by-pass surgery (CABG)
• Valve surgery
• Combined CABG and valve surgery

You may not qualify if:

• Endocarditis
• No possible follow-up
• Planned closure of the left atrium appendage as part of surgery

Sponsors & Collaborators

• Helena DOMINGUEZ: lead
• Rigshospitalet, Denmark: collaborator
• Aarhus University Hospital Skejby: collaborator
• Sahlgrenska University Hospital: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (4)

Aarhus University Hospital Skejby

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

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  PMID: 38741218 DERIVED

• Madsen CL, Park-Hansen J, Irmukhamedov A, Carranza CL, Rafiq S, Rodriguez-Lecoq R, Palmer-Camino N, Modrau IS, Hansson EC, Jeppsson A, Hadad R, Moya-Mitjans A, Greve AM, Christensen R, Carstensen HG, Host NB, Dixen U, Torp-Pedersen C, Kober L, Gogenur I, Truelsen TC, Kruuse C, Sajadieh A, Dominguez H; LAACS-2 trial Investigators. The left atrial appendage closure by surgery-2 (LAACS-2) trial protocol rationale and design of a randomized multicenter trial investigating if left atrial appendage closure prevents stroke in patients undergoing open-heart surgery irrespective of preoperative atrial fibrillation status and stroke risk. Am Heart J. 2023 Oct;264:133-142. doi: 10.1016/j.ahj.2023.06.003. Epub 2023 Jun 10.

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MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena Domínguez, MD, PhD

  Bispebjerg and Frederiksberg Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Open-label, parallel, randomized, control trial

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: March 17, 2019
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From study end until data storage permissions from the Danish Data Protection Agency expire.
• Access Criteria: Reasonable request

Locations

DK (2); SE (1); ES (1)