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Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

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ClinicalTrials.gov Identifier: NCT02272621
Recruitment Status : Recruiting
First Posted : October 23, 2014
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Magnus Dalén, Karolinska University Hospital

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. Twenty patients will be randomly assigned to either partial upper sternotomy (20 patients) or full sternotomy AVR (20 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.

CE-marked and FDA-approved mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Cytokine release will be repeatedly assessed preoperatively and postoperatively (at 0, 6, 12, 18, 24 hours, and 3 days after surgery). Clinical characteristics will be registered. Clinical postoperative ouytcomes 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.


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Heart Valve Diseases Procedure: Minimally invasive aortic valve replacement Procedure: Full sternotomy aortic valve replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Partial upper hemisternotomy aortic valve replacement
Partial upper hemisternotomy AVR will be performed according to current standard of care practices.
Procedure: Minimally invasive aortic valve replacement
Experimental: Full sternotomy aortic valve replacement
Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.
Procedure: Full sternotomy aortic valve replacement



Primary Outcome Measures :
  1. Interleukin-6 [ Time Frame: Postoperatively at 0-3 days ]
  2. Interleukin-8 [ Time Frame: Postoperatively at 0-3 days ]
  3. Interleukin-10 [ Time Frame: Postoperatively at 0-3 days ]
  4. Tumor necrosis factor-alpha [ Time Frame: Postoperatively at 0-3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272621


Contacts
Contact: Peter Svenarud, MD, PhD +46 (0) 8 517 708 12 peter.svenarud@karolinska.se

Locations
Sweden
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Peter Svenarud, MD, PhD    +46 (0) 8 517 708 12    peter.svenarud@karolinska.se   
Principal Investigator: Peter Svenarud, MD, PhD         
Sub-Investigator: Magnus Dalén, MD         
Sub-Investigator: Ulrik Sartipy, MD, PhD         
Sub-Investigator: Anders Franco-Cereceda, MD, PhD         
Sub-Investigator: Mikael Kastengren, MD         
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet

Responsible Party: Magnus Dalén, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02272621     History of Changes
Other Study ID Numbers: CMILE-C
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction