NCT03677804

Brief Summary

The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

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

August 2, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

September 11, 2018

Last Update Submit

June 12, 2019

Conditions

Aortic Valve Disease

Keywords

aortic valve reconstructionOZAKI techniqueautologous pericardium

Outcome Measures

Primary Outcomes (1)

  • Change in aortic transvalvular gradient measured by transthoracic echocardiography

    Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography

    From Baseline (end of cardiac surgery) until 12 months after cardiac surgery

Secondary Outcomes (3)

  • occurence of death

    From Baseline (end of cardiac surgery) until 12 months after cardiac surgery

  • occurence of cardiac re-surgery

    From Baseline (end of cardiac surgery) until 12 months after cardiac surgery

  • occurence of stroke

    From Baseline (end of cardiac surgery) until 12 months after cardiac surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) in Universitätsspital Basel/ Switzerland since September 2015.

You may qualify if:

  • aortic valve reconstruction using autologous Pericardium (OZAKI technique)

You may not qualify if:

  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzchirurgie University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Koechlin L, Schurr U, Miazza J, Imhof S, Maurer M, Erb J, Gahl B, Santer D, Berdajs D, Eckstein FS, Reuthebuch O. Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World J Surg. 2020 Sep;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.

    PMID: 32458022DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Oliver Reuthebuch, PD Dr. med

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 19, 2018

Study Start

August 2, 2017

Primary Completion

May 1, 2019

Study Completion

June 12, 2019

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations

CH(1)