Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement

NCT ID: NCT04632095

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2022-11-15

Brief Summary

Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.

Detailed Description

The classic surgical treatment of aortic stenosis is valve replacement through complete midline opening of the breastbone (median sternotomy) and use of cardiopulmonary bypass (CPB). Risks of this procedure are related to both the surgical approach and the use of CPB. Using minimally invasive approaches in non-cardiac patients (e.g laparoscopy) resulted in reduced postoperative inflammatory response when compared to patients undergoing the same procedures carried out with a conventional "open" technique. Minimally invasive surgical approaches in which the sternum is partially opened (partial sternotomy) or not opened at all (parasternal access) have thus far shown similar procedure related mortality and lower incidence of perioperative complications, despite longer CPB times. Our single center experience thus far suggests superiority of parasternal aortic valve replacement (O/E ratio of 0.19 over the last 2 years), as well as a reduced postoperative inflammatory response (as measured by lower CRP (C reactive protein ) levels taken 6 hours post-surgery). However, these data have several confounders and there is currently no prospective randomized trial addressing this topic. We therefore conduct a randomized comparison of parasternal versus classic sternotomy aortic valve replacement. Based on our previous experience, we expect very low mortality risk in both groups (expected ≤ 1%). The primary endpoint is therefore quality of life assessed using the SF-36 (Short Form) health survey questionnaire. This approach is similar to other current large multicenter trials. In order to address the impact of reduced surgical trauma on inflammatory response; we will quantify an established panel of inflammatory markers (PCT, CRP, interleukin 6) and use bio-banking to allow for further in depth analysis later on. Standardized clinical endpoints will be analyzed as additional secondary parameters. Power analysis determined a number of 50 patients allocated to 2 equal groups to achieve a power of 80%. The parasternal approach is expected to be superior when compared to sternotomy in both the primary and some, if not most, secondary endpoints. We expect our study to become an important milestone for decision-making in the treatment of aortic stenosis. Patients currently fear sternotomy, but the less invasive transcatheter valve implantation appears to be limited by inferior long-term outcome. The parasternal, sternotomy-sparing, classic aortic valve replacement is therefore an attractive therapeutic alternative. Our investigation in relation to systemic inflammatory response will further shed light on the underlying mechanisms explaining differences in clinical outcomes.

Conditions

Aortic Valve Stenosis

Study Design

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

Study Groups

Sternotomy AVR

Aortic valve replacement due to sternotomy

Group Type: ACTIVE_COMPARATOR

Aortic valve replacement due to sternotomy

Intervention Type: PROCEDURE

conventional surgery of aortic stenosis

Mini AVR

Aortic valve replacement due to parasternal right anterior mini-thoracotomy

Group Type: ACTIVE_COMPARATOR

Aortic valve replacement due to parasternal right anterior mini-thoracotomy

Intervention Type: PROCEDURE

surgery of aortic stenosis in minimally invasive technique

Interventions

Aortic valve replacement due to sternotomy

conventional surgery of aortic stenosis

Intervention Type: PROCEDURE

Aortic valve replacement due to parasternal right anterior mini-thoracotomy

surgery of aortic stenosis in minimally invasive technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Indication for elective isolated aortic valve replacement
• Anatomical suitability for both sternotomy and parasternal access
• Age ≥ 18
• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

• Planned simultaneous cardiac surgery interventions (Mitral valve surgery, tricuspid valve surgery, CABG, Pacemaker or defibrillator implantation, Pulmonalvenenisolation, Maze, closure of left atrial appendage , patent foramen ovale or atrial septal defect closure)
• Acute myocardial infarction within 4 weeks, coronary heart disease
• Acute endocarditis
• TIA or stroke within 6 months prior to the procedure
• Pregnant or breast-feeding women
• Renal failure requiring dialysis
• Ejection fraction ≤ 30%
• Re-operation
• Disease with a life expectancy < 2 years
• Therapy with glucocorticoids or immunosuppressants

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

Sponsors

The German Heart Foundation

OTHER

Sponsor Role: collaborator

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Tkebuchava, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Jena

Torsten Doenst, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Jena

Locations

UKJ

Jena, Thuringia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sophie Tkebuchava, MD

Role: CONTACT

sophio.tkebuchava@med.uni-jena.de

+4936419322928

Torsten Doenst, MD

Role: CONTACT

doenst@med.uni-jena.de

+4936419322901

Other Identifiers

PASTA-UKJ

Identifier Type: -

Identifier Source: org_study_id