Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position

October 28, 2015 updated by: Medtronic Bakken Research Center

Mosaic Ultra Porcine Bioprosthesis - Hemodynamic Study

The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcification and improves hemodynamic performance and a potential for increased durability. This study will document the hemodynamic performance, as assessed by echocardiographic recordings, at six months post implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

1.0 STUDY PLAN 1.1. Study Objectives The objective of this clinical study is to evaluate the hemodynamic performance of the Mosaic Ultra™ stented porcine bioprosthesis in the aortic position.

1.2. Study Design This will be a prospective non randomized multi center clinical study designed to obtain hemodynamic data on the Mosaic Ultra™ stented porcine bioprosthesis. All participating centers follow a common clinical investigation plan.

1.3. Sample Size and Study Duration The basis for this study will be at least 60 MosaicÒ Ultra™ stented porcine bioprosthesis implants followed for six months.

2.0 PATIENT SELECTION 2.1. Patient Eligibility Criteria The patient population includes all patients who require aortic valve replacement for heart valve disease (acquired or congenital) and who are candidates for a bioprosthetic valve. Patients will be informed about the aspects of this study and will be asked to give their Informed Consent. The patient population must be geographically stable and able to attend one follow-up examination at the implanting center. Patients not willing or unable to fully participate in the follow-up will not be entered in the study.

2.2. Inclusion Criteria

  • Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of Atrial Fibrillation.
  • Patients who are able to provide informed consent.

3.3. Exclusion Criteria

  • Concomitant procedures other than coronary artery bypass grafting or surgical treatment of Atrial Fibrillation.
  • Patients indicated for receiving a mechanical prosthesis.
  • Patients who will have a replacement of an existing valve prosthesis.
  • Patients refusing or not able to provide informed consent.
  • Patients requiring emergency surgery.

4.0 STUDY METHODS 4.1. Data Requirements For each patient enrolled in the study, information will be collected pre-operatively, operatively, and at 6 months post-operatively.

Patients entering the study are preoperatively evaluated for clinical information. Upon implant of the Mosaic bioprostheses the appropriate surgical data will be obtained. Follow-up data are required at discharge and six months post-operative. Endpoint for each patient in the study will be the six months follow-up.

The required variables are specified on each CRF. Samples of the CRF's are provided in Appendix C. Transthoracic echocardiography is required at pre-op and at six months.

All centers will be provided with a unique center ID. Enrolled patients will be identified on the CRF's by using the center ID with a sequential three digit number.

4.2. Case Report Form (CRF) Completion All appropriate sections of the case report forms must be filled out completely and accurately in black or blue ink. Before submission to Medtronic the investigator (or designated co-investigator) must review, sign and date the CRFs. The original is sent to Medtronic, and a copy remains at the center in the patient study file. All efforts should be made to submit CRFs to Medtronic within 6 weeks after the examination.

4.3. Study File A study file will be set up and maintained by the study center. This will be the repository for all records related to the study. All case report forms should be traceable to source documents. Source documents must be maintained in the patient medical records.

5.0 DATA ANALYSIS AND REPORTING 5.1. Data ownership All data collected in this study will be regarded as confidential and will be entered in a common database that is the property of Medtronic.

5.2. Data analysis Appropriate statistical analysis will be performed to compare the hemodynamic performance of various sizes. Hemodynamic data will be summarized by valve size. Descriptive statistics will be employed to report patient population characteristics, operative and post-operative data.

5.3. Data reporting Medtronic will complete and submit to the participating investigators a complete report using all collected data.

5.4. Publication policy It is the intent of both Medtronic and the study center that the investigator publish the results of this study. Medtronic may elect to use the data and outcomes of this study for the promotion of its products. Investigator will provide a copy of any abstract, presentation, and/or manuscript to Medtronic at least thirty (30) days prior to submission. Medtronic has the right to review the publications for confidential information, copyright materials and to edit for technical accuracy prior to submission.

6.0 STUDY MANAGEMENT 6.1. Study Sponsor and Contact Staff Medtronic Bakken Research Center B.V. is the sponsor of this study

Bèr Kleijnen, Sr. Clinical Research Specialist, will be the contact person for the overall study coordination:

Bèr Kleijnen Sr. Clinical Research Specialist Cardiac Surgery Clinical Operations Bakken Research Center B.V. Endepolsdomein 5 6229 GW Maastricht The Netherlands email:ber.kleijnen@medtronic.com

Your local Sales representative will be the contact person for the daily coordination and data collection:

6.2. Records Retention Records must be retained at each clinical site for a period of 2 years after the date the study is completed or terminated, and in accordance with local record retention requirement.

Medtronic will maintain clinical study records permanently. .

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Medinische Universitat Innsbruck
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis
      • Bouge, Belgium, 5004
        • Hopital St Luc
    • Antwerp
      • Antwerpen, Antwerp, Belgium, 2020
        • Zna Middelheim
  • Germany
      • Dortmund, Germany, 44139
        • Klinik fur Thorax- Herz und Gefasschirurgie
      • Frankfurt am Mein, Germany, 60590
        • Klinikum der Johann-Wolfgang-Goethe Universität
      • Hamburg, Germany, 22457
        • Albertinen Krankenhaus
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel, 91120
        • Hadasit Medical Research Services
  • Italy
      • Palermo, Italy, 90127
        • U.O. Cardiochirurgia del p.p. Civico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are eligible for an aortic valve replacement can be enrolled in the study.

Description

Inclusion Criteria:

  • Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of Atrial Fibrillation.
  • Patients who are able to provide informed consent.

Exclusion Criteria:

  • Concomitant procedures other than coronary artery bypass grafting or surgical treatment of Atrial Fibrillation.
  • Patients indicated for receiving a mechanical prosthesis.
  • Patients who will have a replacement of an existing valve prosthesis.
  • Patients refusing or not able to provide informed consent.
  • Patients requiring emergency surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Investigators

  • Study Director: Jaak Minten, PhD, Clinical Director Cardiac Surgery Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 22, 2007

First Posted (ESTIMATE)

May 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BRC-CS-14075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe