MISSION-Registry: Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve Systyem in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry.

MISSION-Registry: Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve Systyem in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry. - MISSION-Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45758

Enrollment

Registered

2016-09-15

Start date

2016-10-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic valve stenosis heart valve restriction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Subject is 18 years or older 2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines. 3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy. 4. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed. 5. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

Exclusion criteria

Exclusion criteria: 1. Subject is diagnosed with pure aortic insufficiency. 2. Subject requires multiple valve replacement/repair 3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. 4. Subject has severe ventricular dysfunction defined as LVEF

Design outcomes

Primary

Measure	Time frame
Aortic Cross Clamp time	—

Secondary

Measure	Time frame
Secondary endpoints: Cardiopulmonary bypass time Procedure time Valve implant time Device technical success (defined as the successful delivery and deployment of a study valve and delivery system and subject leaving the operating room with valve in place) First Attempt Success Rate ICU and Hospital Length of Stay Hemodynamic performance (mean gradient, peak gradient, effective orifice area [EOA], EOA index, performance index, cardiac output [CO], cardiac index [CI], valvular regurgitation [including paravalvular leak]) confirmed by an Echocardiographic Core Laboratory at Discharge and 6 months (if available) Patient related endpoints: NYHA functional class compared to baseline Change in Quality of Life questionnaire Form 36 (SF-36) and EQ-5D from Screening to 6 months Fitness for hospital Discharge Safety endpoints: Complication rates at 30 days (early rates) and at 6 months : All cause mortality o Study valve-related mortality Thromboembolism o Stroke o TIA o Non cerebral embolism Valve Thrombosis Major Bleeding event Endocarditis (study valve) Structural valve deterioration Non Structural valve deterioration o Paravalvular Leak minor o Paravalvular Leak major o Other non SVD Reoperation o Trial valve reoperation Hemolysis Study valve explants Implant-related new or worsened cardiac conduction disturbance requiring permanent pacemaker implant Renal Failure Respiratory dysfunction Deep Sternal Wound infection The Clinical Events Committee (CEC) will evaluate the adverse events including adverse events resulting in death as outlined in their charter and adjudicate these events for their relatedness to the investigational device, and the investigational device procedure.	—

Measure

Time frame

Secondary endpoints: Cardiopulmonary bypass time Procedure time Valve implant time Device technical success (defined as the successful delivery and deployment of a study valve and delivery system and subject leaving the operating room with valve in place) First Attempt Success Rate ICU and Hospital Length of Stay Hemodynamic performance (mean gradient, peak gradient, effective orifice area [EOA], EOA index, performance index, cardiac output [CO], cardiac index [CI], valvular regurgitation [including paravalvular leak]) confirmed by an Echocardiographic Core Laboratory at Discharge and 6 months (if available) Patient related endpoints: NYHA functional class compared to baseline Change in Quality of Life questionnaire Form 36 (SF-36) and EQ-5D from Screening to 6 months Fitness for hospital Discharge Safety endpoints: Complication rates at 30 days (early rates) and at 6 months : All cause mortality o Study valve-related mortality Thromboembolism o Stroke o TIA o Non cerebral embolism Valve Thrombosis Major Bleeding event Endocarditis (study valve) Structural valve deterioration Non Structural valve deterioration o Paravalvular Leak minor o Paravalvular Leak major o Other non SVD Reoperation o Trial valve reoperation Hemolysis Study valve explants Implant-related new or worsened cardiac conduction disturbance requiring permanent pacemaker implant Renal Failure Respiratory dysfunction Deep Sternal Wound infection The Clinical Events Committee (CEC) will evaluate the adverse events including adverse events resulting in death as outlined in their charter and adjudicate these events for their relatedness to the investigational device, and the investigational device procedure.

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Countries

Netherlands

Outcome results