NCT02324140

Brief Summary

The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

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

June 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

2.7 years

First QC Date

December 15, 2014

Last Update Submit

July 13, 2015

Conditions

InflammationSystemic Inflammatory Response SyndromeThoracic SurgeryAortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)

    Perioperative period ending after 48 hours postoperatively

Secondary Outcomes (2)

  • Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)

    Perioperative period ending after 48 hours postoperatively

  • In-hospital mortality

    In-hospital treatment until discharge (7-10 days)

Study Arms (4)

Minimized extracorporeal circulation

Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1)

Other: Whole blood analysis

Conventional extracorporeal circulation

Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2)

Other: Whole blood analysis

Transcatheter aortic valve implantation, transfemoral access

Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route

Other: Whole blood analysis

Transcatheter aortic valve implantation, transapical access

Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route

Other: Whole blood analysis

Interventions

Whole blood analysisOTHER

In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.

Conventional extracorporeal circulationMinimized extracorporeal circulationTranscatheter aortic valve implantation, transapical accessTranscatheter aortic valve implantation, transfemoral access

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe aortic valve stenosis selected for surgical aortic valve replacement or transcatheter aortic valve implantation.

You may qualify if:

  • Written informed consent
  • Severe aortic valve stenosis
  • Surgical aortic valve replacement
  • Transcatheter aortic valve implantation
  • No previous inflammatory condition

You may not qualify if:

  • Missing informed consent
  • Treatment with corticosteroids
  • Treatment with antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. Anesthesiology and Pain Therapy

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood analysis

MeSH Terms

Conditions

InflammationSystemic Inflammatory Response SyndromeAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsShockAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Frank Stüber, MD, Prof.

    Dep. Anesthesiology and pain Therapy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2014

First Posted

December 24, 2014

Study Start

June 1, 2012

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

CH(1)