Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
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|ClinicalTrials.gov Identifier: NCT00853632|
Recruitment Status : Active, not recruiting
First Posted : March 2, 2009
Last Update Posted : September 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Mitral Valve Regurgitation Mitral Valve Incompetence Heart Failure||Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES||Not Applicable|
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 will be collected from each subject preoperatively, at 6 months and annually post implant through 8 year follow-ups. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
|Device - CEP Mitral Valve||
Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Mitral valve replacement
Other Name: Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX
- Primary Safety Endpoints [ Time Frame: Long term safety performance ]
Long term safety performance will be evaluated by comparing the linearized rates listed below to the objective performance criteria referenced in ISO 5840- 2005, Cardiovascular Implants-Cardiac Valve Prostheses.
- All Hemorrhage
- All Perivalvular Leak
- Primary Effectiveness Endpoints [ Time Frame: 8 years post-implant ]The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.
- Secondary Safety Endpoints [ Time Frame: Long term safety performance ]
Early & late linearized & actuarial analysis of:
- Valve thrombosis
- All hemorrhage
- Major hemorrhage
- All perivalvular leak
- Major perivalvular leak
- Structural valve deterioration
- Non-structural valve dysfunction
- Valve-related death
- Secondary Safety Endpoints [ Time Frame: 6 month, 1 year and annual follow-up visits ]Blood studies including white blood count, red blood count, hematocrit, plasma free hemoglobin (or haptoglobin and SLDH), platelet and reticulocyte counts will be used to evaluate the rate of hemolysis and adverse events at the 6 month, 1 year and annual follow-up visits.
- Secondary Effectiveness Endpoints [ Time Frame: 8 years post-implant ]
The secondary Effectiveness endpoints will be: Hemodynamic Performance by echocardiography at 8 years post implant, which includes:
- Peak Gradient
- Mean Gradient
- Effective Orifice Area
- Effective Orifice Area Index
- Performance Index
- Cardiac Output
- Cardiac Index
- Severity of Valvular Regurgitation
- LV Mass Regression
- Secondary Effectiveness Endpoints [ Time Frame: 6 months post-implant ]Quality of Life Survey (EQ-5D) at 6 month post index procedure as compared to preoperative baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853632
|Study Director:||Mary Edwards||Edwards Lifesciences|