Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT00853632
First received: February 26, 2009
Last updated: April 15, 2014
Last verified: April 2014

February 26, 2009
April 15, 2014
August 2007
December 2014   (final data collection date for primary outcome measure)
Long term safety performance will be evaluated by comparing the linearized yearly rates listed below to the objective performance criteria referenced in the 1994 FDA's Heart Valve Guidance: • Thromboembolism • All Hemorrhage [ Time Frame: Long term safety performance ] [ Designated as safety issue: Yes ]
Long term safety performance will be evaluated by comparing the linearized yearly rates listed below to the objective performance criteria referenced in the 1994 FDA's Heart Valve Guidance: • Thromboembolism • All Hemorrhage
Complete list of historical versions of study NCT00853632 on ClinicalTrials.gov Archive Site
Safety: Early & late linearized & actuarial analysis of: TE,Valve thrombosis, All hemorrhage & PV leak Endocarditis Hemolysis SVD NSVD Reop Explant Death Blood Data Effectiveness:Echo Hemodynamic Performance 8 yrs post implant QOL Survey EQ-5D [ Time Frame: Long term safety performance ] [ Designated as safety issue: Yes ]
Safety:Early & late linearized & actuarial analysis of: TE,Valve thrombosis All hemorrhage & perivalvular leak Endocarditis Hemolysis SVD NSVD Reop Explant Death Blood Data Effectiveness:Echo Hemodynamic Performance 8 yrs post implant QOL Survey EQ-5D
Not Provided
Not Provided
 
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

This is a prospective, single-arm, multi-center study to be conducted in the US and outside the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250, approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements. Subject enrollment will not start in the US before obtaining FDA approval of this post market study.

Assessments will be obtained for the preoperative and operative visits, and postoperatively at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications and coagulation profile. Blood data is required for each subject preoperatively and at 6 months. Echocardiographic evaluation required for each subject preoperatively, at discharge, 6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will be completed by the subject pre-operatively and at the 6-month follow-up visit.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Mitral Valve Regurgitation
  • Mitral Valve Incompetence
  • Heart Failure
Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Mitral valve replacement
Other Name: Magna Mitral 7000/7000TFX
Device - CEP Mitral Valve
Intervention: Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2023
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
  • The patient has signed and dated the subject informed consent form prior to surgery.
  • The patient is expected to survive the surgery and be discharged.
  • The patient is geographically stable and agrees to attend follow-up assessments.
  • The patient is 18 years or older.

Exclusion Criteria:

  • The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
  • The patient presents with active endocarditis within the last 3 months.
  • The patient is pregnant or lactating.
  • The patient is an intravenous drug abuser.
  • The patient is currently a prison inmate.
  • The patient is currently participating in a study of an investigational drug or device.
  • The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
  • The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)*.
  • The patient was previously enrolled in the study.
  • The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.
Both
18 Years and older
No
Contact: Bruce Van Deman 949-250-2626 bruce_van_deman@edwards.com
Belgium,   United States,   Germany,   Austria,   Canada,   Switzerland
 
NCT00853632
Study# 2006-05
No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Study Director: Bruce Van Deman Edwards Lifescience
Edwards Lifesciences
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP