NCT02272621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

6.9 years

First QC Date

October 21, 2014

Last Update Submit

May 31, 2021

Conditions

Aortic Valve StenosisHeart Valve Diseases

Outcome Measures

Primary Outcomes (1)

  • Universal definition of perioperative bleeding in adult cardiac surgery

    Within 3 days from surgery

Study Arms (2)

Partial upper hemisternotomy aortic valve replacement

EXPERIMENTAL

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

Procedure: Minimally invasive aortic valve replacement

Full sternotomy aortic valve replacement

EXPERIMENTAL

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

Procedure: Full sternotomy aortic valve replacement

Interventions

Minimally invasive aortic valve replacementPROCEDURE
Partial upper hemisternotomy aortic valve replacement
Full sternotomy aortic valve replacementPROCEDURE
Full sternotomy aortic valve replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • Left ventricular ejection fraction less than 0.45
  • Presence of any coexisting severe valvular disorder
  • Previous cardiac surgery
  • Urgent or emergent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 38907320DERIVED

  • 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.

    PMID: 38054555DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

November 1, 2013

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations

SE(1)