NCT03346044

Brief Summary

The study compares the clinical performance of the Mosaic valve with that of the Baxter valve (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the "bench mark". Specific objectives will be to determine structural failure and valve explantation rates, thromboembolic events and mortality rates for each valve. Haemodynamic assessments will also be made using echocardiography to measure gradients across the valves and changes in left ventricular function and wall thickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
428

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

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

January 1, 2001

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2006

Completed
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

5.1 years

First QC Date

September 8, 2017

Last Update Submit

November 14, 2017

Conditions

Cardiac Valve Replacement

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Early mortality was defined as death occurring within 30 days of implantation if the patient was discharged from hospital or at any time after implantation if the patient was not discharged from hospital. Hospital-to-hospital transfer was not considered as discharge. Late mortality was defined as all deaths that occurred after 30 days of implant, if the patient was discharged from hospital. The reporting of mortality and morbidity follows the guidelines of the Society of Thoracic Surgeons (STS), the American Association of Thoracic Surgeons (AATS) and the European Association for Cardiothoracic Surgery (EACTS). () Edmunds LH, Clark R, Cohn L, et al. Guidelines for Reporting Morbidity and MortalityAfter Cardiac Valvular Operations. Ann Thorac Surg 1996;62:932-5)

    10 years

  • Freedom from structural valve deterioration (SVD)

    Defined as re-operation and thromboembolic events. Valve-related complications were defined as thromboembolism, structural valve dysfunction, non-structural valve dysfunction and prosthetic valve endocarditis.

    10 years

Secondary Outcomes (2)

  • Haemodynamic performance (mmHg)

    10 years

  • Left ventricular (LV) mass regression (grams)

    10 years

Study Arms (2)

Carpentier-Edwards SAV bioprostheses

ACTIVE COMPARATOR
Device: Carpentier-Edwards SAV bioprostheses

Medtronic Mosaic bioprostheses

ACTIVE COMPARATOR
Device: Medtronic Mosaic bioprostheses

Interventions

Carpentier-Edwards SAV bioprosthesesDEVICE

Performance of these bioprostheses

Carpentier-Edwards SAV bioprostheses
Medtronic Mosaic bioprosthesesDEVICE
Medtronic Mosaic bioprostheses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who require isolated or combined aortic or mitral valve replacement with or without coronary artery bypass grafting
  • Patients requesting anticoagulation-free therapy
  • Patients who are able to provide informed consent

You may not qualify if:

  • Concomitant procedures other than coronary artery bypass grafting
  • Presence of illness other than valve disease that would substantially increase the likelihood of death within one year
  • Patients unlikely to be available for long term follow-up activities
  • Patients indicated for receiving a mechanical prosthesis
  • Patients refusing or not able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

Location

Related Publications (1)

  • Zibdeh O, Bugg I, Patel S, Twine G, Unsworth-White J. Randomized trial of the Carpentier-Edwards supra-annular prosthesis versus the Medtronic Mosaic aortic prosthesis: 10-year results. Eur J Cardiothorac Surg. 2018 Aug 1;54(2):281-287. doi: 10.1093/ejcts/ezx512.

    PMID: 29401266DERIVED

Study Officials

  • Jonathan Unsworth-White, BSc FRCS

    University Hospital Plymouth NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A comparative single centre study of two porcine bioprostheses indicated for the surgical treatment of heart valve diseases. The study will compare two equal sized patient groups using either the Medtronic Mosaic and Carpentier-Edwards SAV bioprostheses.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiothoracic Surgeon

Study Record Dates

First Submitted

September 8, 2017

First Posted

November 17, 2017

Study Start

January 1, 2001

Primary Completion

February 2, 2006

Study Completion

January 12, 2016

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

GB(1)