Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02272621

Enrollment

100

Registered

2014-10-23

Start date

2013-11-30

Completion date

2020-10-31

Last updated

2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Heart Valve Diseases

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.

Interventions

PROCEDUREMinimally invasive aortic valve replacement

PROCEDUREFull sternotomy aortic valve replacement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Universal definition of perioperative bleeding in adult cardiac surgery	Within 3 days from surgery

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026