NCT04010396

Brief Summary

In the first retrospective part of the study the investigators will conduct a data analysis of patients having received a bovine aortic graft. The investigators will analyze charts and CT / MRI at various time intervals and identify if there are signs of inflammation. In the second prospective part the investigators will select survivors from the first part with and without inflammation signs. If they consent to participate in the study the investigators will do a blood sampling in order to perform further immunological analysis. Additionally, the investigators will examine their quality of life by QoL SF-12 questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

July 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

July 3, 2019

Last Update Submit

November 22, 2021

Conditions

Immune Defect

Outcome Measures

Primary Outcomes (1)

  • Inflammatory Response

    Percentage of patients having received the bovine conduit graft showing a graft inflammation.

    postoperatively, up to 30 years

Secondary Outcomes (1)

  • Inflammatory Response in Control Group

    postoperatively, up to 30 years

Study Arms (2)

Recipients of Bovine Graft

Recruitment and informed consent procedure for blood sampling to conduct immunological testing. In addition a questionnaire on QOL (SF-12) will be used to evaluate the most actual quality of life of these patients.

Other: Blood sampling

Recipients of Mechanical Graft

Recruitment and informed consent procedure for blood sampling to conduct immunological testing. In addition a questionnaire on QOL (SF-12) will be used to evaluate the most actual quality of life of these patients.

Other: Blood sampling

Interventions

Blood samplingOTHER

Blood sampling: 1 EDTA and 1 Serum vial

Recipients of Bovine GraftRecipients of Mechanical Graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Part 1: n=116 bovine (total amount of recipients of the Shelhigh graft at the investigators' institution). 50 (mechanical control) Part 2: n= 10 (bovine with immune response) +10 (bovine without immune response) +10 (mechanical control)

You may qualify if:

  • Recipients of the bovine graft or mechanical graft. For the prospective part 2: able to give informed consent by signature, age, matching characteristics and time frame.

You may not qualify if:

  • Individuals of the patient cohort from the last 20 years who indicated that their data cannot be utilized for future research will be excluded from the study.
  • Inability or any contraindications to undergo the planned investigated intervention, clinically significant concomitant diseases precluding ambulatory control in the day clinic in Bern.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bern, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (9)

  • Carrel TP, Schoenhoff FS, Schmidli J, Stalder M, Eckstein FS, Englberger L. Deleterious outcome of No-React-treated stentless valved conduits after aortic root replacement: why were warnings ignored? J Thorac Cardiovasc Surg. 2008 Jul;136(1):52-7. doi: 10.1016/j.jtcvs.2007.09.047. Epub 2008 May 27.

    PMID: 18603053BACKGROUND

  • Carrel T, Reineke D, Englberger L. Another report on unfavourable long-term outcome following implantation of the Shelhigh No-React valved tube graft. Eur J Cardiothorac Surg. 2016 Dec;50(6):1179-1180. doi: 10.1093/ejcts/ezw205. Epub 2016 Jun 14. No abstract available.

    PMID: 27307482BACKGROUND

  • Reineke DC, Kaya A, Heinisch PP, Oezdemir B, Winkler B, Huber C, Heijmen RH, Morshuis W, Carrel TP, Englberger L. Long-term follow-up after implantation of the Shelhigh(R) No-React(R) complete biological aortic valved conduit. Eur J Cardiothorac Surg. 2016 Jul;50(1):98-104. doi: 10.1093/ejcts/ezv452. Epub 2015 Dec 30.

    PMID: 26719402BACKGROUND

  • Gisler F, Huber C, Wenaweser P, Carrel T. Severe calcification of a Shelhigh stentless valved conduit. Eur J Cardiothorac Surg. 2014 Aug;46(2):334. doi: 10.1093/ejcts/ezt569. Epub 2013 Dec 11. No abstract available.

    PMID: 24335263BACKGROUND

  • Schoenhoff FS, Loup O, Gahl B, Banz Y, Pavlovic M, Pfammatter JP, Carrel TP, Kadner A. The Contegra bovine jugular vein graft versus the Shelhigh pulmonic porcine graft for reconstruction of the right ventricular outflow tract: a comparative study. J Thorac Cardiovasc Surg. 2011 Mar;141(3):654-61. doi: 10.1016/j.jtcvs.2010.06.068. Epub 2011 Jan 20.

    PMID: 21255796BACKGROUND

  • Carrel TP. Another disastrous outcome following aortic root replacement with the Shelhigh No-react aortic valved tube. Thorac Cardiovasc Surg. 2008 Aug;56(5):314-5. doi: 10.1055/s-2008-1038472. No abstract available.

    PMID: 18615385BACKGROUND

  • Englberger L, Noti J, Immer FF, Stalder M, Eckstein FS, Carrel TP. The Shelhigh No-React bovine internal mammary artery: a questionable alternative conduit in coronary bypass surgery? Eur J Cardiothorac Surg. 2008 Feb;33(2):222-4. doi: 10.1016/j.ejcts.2007.11.006. Epub 2007 Dec 20.

    PMID: 18083039BACKGROUND

  • Sahin A, Muggler O, Sromicki J, Caliskan E, Reser D, Emmert MY, Alkadhi H, Maisano F, Falk V, Holubec T. Long-term follow-up after aortic root replacement with the Shelhigh(R) biological valved conduit: a word of caution! Eur J Cardiothorac Surg. 2016 Dec;50(6):1172-1178. doi: 10.1093/ejcts/ezw167. Epub 2016 May 26.

    PMID: 27229673BACKGROUND

  • Kaya A, Heijmen RH, Kelder JC, Schepens MA, Morshuis WJ. Stentless biological valved conduit for aortic root replacement: initial experience with the Shelhigh BioConduit model NR-2000C. J Thorac Cardiovasc Surg. 2011 May;141(5):1157-62. doi: 10.1016/j.jtcvs.2010.07.009. Epub 2010 Sep 15.

    PMID: 20832085BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples (1 EDTA + 1 Serum vial)

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • ThierryThierry Prof. Dr. med. Carrel

    Department Chair

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 8, 2019

Study Start

September 1, 2019

Primary Completion

December 31, 2019

Study Completion

April 30, 2020

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)