NCT03667274

Brief Summary

To compare patient outcome data after cardiac double valve replacement (aortic and mitral valve) with patient outcome data after aortic valve replacement and mitral valve reconstruction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

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

April 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

September 10, 2018

Last Update Submit

June 21, 2021

Conditions

Cardiac Double Valve Replacement

Keywords

aortic valve replacementmitral valve reconstructionmitral valve replacement

Outcome Measures

Primary Outcomes (3)

  • death

    death after cardiac valve surgery

    time from hospitalisation for cardiac valve surgery and following 12 months

  • re-surgery

    re-surgery after cardiac valve surgery

    time from hospitalisation for cardiac valve surgery and following 12 months

  • change in transvalvular gradient

    change in transvalvular Gradient after cardiac valve surgery

    time from hospitalisation for cardiac valve surgery and following 12 months

Interventions

cardiac valve surgeryPROCEDURE

cardiac double valve surgery (aortic and mitral valve)

Eligibility Criteria

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

patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009

You may qualify if:

  • patients undergoing cardiac double valve surgery (aortic valve replacement, mitral valve replacement, mitral valve reconstruction) at University Hospital Basel/ Switzerland, starting 2009

You may not qualify if:

  • denial of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzchirurgie University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Egger ML, Gahl B, Koechlin L, Schomig L, Matt P, Reuthebuch O, Eckstein FS, Grapow MTR. Outcome of patients with double valve surgery between 2009 and 2018 at University Hospital Basel, Switzerland. J Cardiothorac Surg. 2022 Jun 13;17(1):152. doi: 10.1186/s13019-022-01904-9.

    PMID: 35698233DERIVED

Study Officials

  • Martin Grapow, Prof. Dr. MD

    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 10, 2018

First Posted

September 12, 2018

Study Start

April 1, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

June 22, 2021

Record last verified: 2021-06

Locations

CH(1)