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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT02321137
• Date of registration: 11/12/2014
• Prospective Registration: No
• Primary sponsor: University of Turku
• Public title: Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery LAA-CLOSURE
• Scientific title: A Randomized Prospective Multicenter Trial for Stroke Prevention by Surgical Occlusion of the Left Atrial Appendage in Patients Undergoing Aortic Bioprosthetic Surgery
• Date of first enrolment: November 2014
• Target sample size: 1040
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02321137
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Finland, Netherlands

Contacts

• Name: Tuomas Kiviniemi, MD, PhD
• Affiliation: Turku University Hospital, Turku, Finland

• Name: Tuija Vasankari, RN

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Stenosis

Intervention(s)

Procedure: Surgical closure of left atrial appendage

Procedure: No closure of left atrial appendage

Primary Outcome(s)

A composite of stroke, systemic embolism and cardiovascular mortality [Time Frame: 5 years]

Secondary Outcome(s)

cardiovascular mortality [Time Frame: 5 years]

Major bleeding (BARC 3a, b, c or 5) [Time Frame: 5 years]

Net adverse events (primary endpoint and major bleeding) [Time Frame: 5 years]

A composite outcome of any of the following: stroke, systemic embolism and cardiovascular mortality [Time Frame: 30 days postoperatively]

Any bleeding (BARC 1, 2 3a, b, c or 5) [Time Frame: 5 years]

stroke/systemic embolism [Time Frame: 5 years]

Stroke [Time Frame: 30 days postoperatively]

Hospitalization for decompensated heart failure [Time Frame: 5 years]

Surgery related bleeding (BARC 4) [Time Frame: 5 years]

Secondary ID(s)

UTurku

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Helsinki University Central Hospital

Landspitali University Hospital

St. Antonius Hospital

Kuopio University Hospital