Inflammatory Response to Aortic Valve Replacement

NCT03074838 | Completed

• 1 other identifier: 2012/7919
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.

Conditions

Aortic Valve Stenosis

Keywords

Cardiac surgery; TAVI

Outcome Measures

Primary Outcomes (1)

• Generation of several inflammatory markers measured through repeated blood samples

  The total generation of several inflammatory markers is compared between the groups

  24 hours

Secondary Outcomes (2)

• Blood loss

  24 hrs

• Blood transfusion

  24 hrs

Study Arms (2)

Transarterial aortic valve implantation

EXPERIMENTAL

Patients that are treated by trans arterial valve implantation (TAVI)

Procedure: Transarterial aortic valve implantation - TAVI

Surgical aortic valve replacement

ACTIVE COMPARATOR

Patients that are treated by surgical aortic valve replacement (SAVR)

Procedure: Surgical aortic valve replacement - SAVR

Interventions

Transarterial aortic valve implantation - TAVI PROCEDURE

After insertion of a guidewire, either through the femoral artery or through the ascending aorta, the aortic ostium is dilated by a balloon and the valve is introduced through a catheter and expanded in the ostium.

Transarterial aortic valve implantation

Surgical aortic valve replacement - SAVR PROCEDURE

The patient is operated through a sternotomy and coupled to a heart lung machine. The aorta is opened and the native valve excised. Then a biological artificial heart valve is sutured in place.

Surgical aortic valve replacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for aortic valve replacement without need for concurrent surgery

You may not qualify if:

• known inflammatory disease and anti-inflammatory treatment

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Related Publications (1)

• Fiane KKH, Dahle G, Bendz B, Halvorsen PS, Abdelnoor M, Mollnes TE, Fosse E. Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement. Scand Cardiovasc J. 2018 Feb;52(1):43-50. doi: 10.1080/14017431.2017.1416157. Epub 2017 Dec 12.

  PMID: 29233022 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Erik Fosse, MD PhD

  Oslo University Hospital/University of Oslo

  PRINCIPAL INVESTIGATOR

• Karoline KH Fiane, Med Student

  University of Oslo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department, Professor

Model Details: A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 9, 2017
• Study Start: December 1, 2012
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: March 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share