Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

NCT ID: NCT02272621

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2020-10-31

Brief Summary

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.

Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partial upper hemisternotomy aortic valve replacement

Partial upper hemisternotomy AVR will be performed according to current standard of care practices.

Group Type: EXPERIMENTAL

Minimally invasive aortic valve replacement

Intervention Type: PROCEDURE

Full sternotomy aortic valve replacement

Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.

Group Type: EXPERIMENTAL

Full sternotomy aortic valve replacement

Intervention Type: PROCEDURE

Interventions

Minimally invasive aortic valve replacement

Intervention Type: PROCEDURE

Full sternotomy aortic valve replacement

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Magnus Dalén

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiothoracic Surgery, Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

Bratt S, Dimberg A, Kastengren M, Lilford RD, Svenarud P, Sartipy U, Franco-Cereceda A, Dalen M. Bleeding in minimally invasive versus conventional aortic valve replacement. J Cardiothorac Surg. 2024 Jun 21;19(1):349. doi: 10.1186/s13019-024-02667-1.

Reference Type: DERIVED

PMID: 38907320 (View on PubMed)

Kirmani BH, Jones SG, Muir A, Malaisrie SC, Chung DA, Williams RJ, Akowuah E. Limited versus full sternotomy for aortic valve replacement. Cochrane Database Syst Rev. 2023 Dec 6;12(12):CD011793. doi: 10.1002/14651858.CD011793.pub3.

Reference Type: DERIVED

PMID: 38054555 (View on PubMed)

Other Identifiers

CMILE-bleeding

Identifier Type: -

Identifier Source: org_study_id