Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

• Register: ClinicalTrials.gov
• Last refreshed on: 14 June 2021
• Main ID: NCT02272621
• Date of registration: 21/10/2014
• Prospective Registration: No
• Primary sponsor: Karolinska University Hospital
• Public title: Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
• Date of first enrolment: November 2013
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02272621
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- = 18 years of age

- Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area
of 0.6 cm2/m2 by echocardiography

- Referred for medically indicated aortic valve replacement

- Sinus rhythm

- Provide written informed consent

Exclusion Criteria:

- Inclusion in other trial

- Left ventricular ejection fraction less than 0.45

- Presence of any coexisting severe valvular disorder

- Previous cardiac surgery

- Urgent or emergent surgery



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

Health Condition(s) or Problem(s) studied

Heart Valve Diseases

Aortic Valve Stenosis

Intervention(s)

Procedure: Full sternotomy aortic valve replacement

Procedure: Minimally invasive aortic valve replacement

Primary Outcome(s)

Universal definition of perioperative bleeding in adult cardiac surgery [Time Frame: Within 3 days from surgery]

Secondary ID(s)

CMILE-bleeding

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Karolinska Institutet