Inflammatory Response to Aortic Valve Replacement

Status Completed

Clinical Trial 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.

Clinical Trial Description

18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.

A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.

A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Stenosis

Clinical Trial Details

NCT number	NCT03074838
Study type	Interventional
Source	Oslo University Hospital
Contact
Status	Completed
Phase	N/A
Start date	December 1, 2012
Completion date	December 31, 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03186339` - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting	`NCT03549559` - Imaging Histone Deacetylase in the Heart	N/A
Terminated	`NCT02854319` - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System	N/A
Recruiting	`NCT05601453` - The ReTAVI Prospective Observational Registry
Withdrawn	`NCT05481814` - CPX in Paradoxical Low Flow Aortic Stenosis
Completed	`NCT02241109` - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity	N/A
Completed	`NCT01700439` - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve	N/A
Recruiting	`NCT04429035` - SLOW-Slower Progress of caLcificatiOn With Vitamin K2	N/A
Completed	`NCT04103931` - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis	N/A
Completed	`NCT03950440` - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting	`NCT02661451` - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)	N/A
Completed	`NCT02758964` - Evaluation of Cerebral Thrombembolism After TAVR
Completed	`NCT02792452` - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed	`NCT02847546` - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation	N/A
Not yet recruiting	`NCT02541877` - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve	Phase 3
Not yet recruiting	`NCT02536703` - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population	Phase 3
Completed	`NCT02249000` - BIOVALVE - I / II Clincial Investigation	N/A
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Active, not recruiting	`NCT02080299` - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation	Phase 2
Terminated	`NCT01939678` - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease