Assessing standard oF care and clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, active, pOst-market surveillaNce study.

Assessing standard oF care and clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, active, pOst-market surveillaNce study. - FOUNDATION

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39322

Enrollment

Registered

2013-04-25

Start date

2013-02-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Aortic Valve Replacement

Interventions

Not Applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Subject is 18 years or older 2. Subject presents with aortic stenosis or stenosis-based insufficiency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis. 3. Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed. 4. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.

Exclusion criteria

Exclusion criteria: 1. History of active endocarditis within three months of scheduled surgery 2. Subject is diagnosed with pure aortic insufficiency 3. Aneurysm of the aortic root and/or ascending aorta

Design outcomes

Primary

Measure	Time frame
SAFETY ENDPOINTS • All cause mortality • Study valve-related mortality • Hemolysis • Endocarditis • Thromboembolic events • Study valve thrombosis • All perivalvular leak • Bleeding events • Study valve-related reoperation • Structural valve deterioration of study valve • Non-structural valve deterioration of study valve • Study valve explant • Implant-related new or worsening cardiac conduction disturbance EFFECTIVENESS ENDPOINTS • Cross clamp time • Cardiopulmonary bypass time • Valve implant time • Hemodynamic performance: mean gradient, peak gradient, effective orifice area (EOA), EOA index, performance index, cardiac output, cardiac index, valvular regurgitation (including perivalvular leak), end systolic and end diastolic left ventricular volumes confirmed by echocardiography and Core lab evaluation. • Device technical success defined as the successful delivery and deployment of study valve and delivery system. • Length of hospital stay • Length of time in intensive care unit • Study valve reoperation • NYHA functional class compared to baseline • QoL Questionnaire: EQ-5D at baseline and 3 months post procedure	—

Measure

Time frame

SAFETY ENDPOINTS • All cause mortality • Study valve-related mortality • Hemolysis • Endocarditis • Thromboembolic events • Study valve thrombosis • All perivalvular leak • Bleeding events • Study valve-related reoperation • Structural valve deterioration of study valve • Non-structural valve deterioration of study valve • Study valve explant • Implant-related new or worsening cardiac conduction disturbance EFFECTIVENESS ENDPOINTS • Cross clamp time • Cardiopulmonary bypass time • Valve implant time • Hemodynamic performance: mean gradient, peak gradient, effective orifice area (EOA), EOA index, performance index, cardiac output, cardiac index, valvular regurgitation (including perivalvular leak), end systolic and end diastolic left ventricular volumes confirmed by echocardiography and Core lab evaluation. • Device technical success defined as the successful delivery and deployment of study valve and delivery system. • Length of hospital stay • Length of time in intensive care unit • Study valve reoperation • NYHA functional class compared to baseline • QoL Questionnaire: EQ-5D at baseline and 3 months post procedure

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)