Clinical evaluation of percutaneous implantation of the CoreValve aortic valve prosthesis. Safety and performance study on patients at high risk for surgical valve replacement.

Clinical evaluation of percutaneous implantation of the CoreValve aortic valve prosthesis. Safety and performance study on patients at high risk for surgical valve replacement. - CoreValve generation 3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29825

Enrollment

Registered

2006-10-03

Start date

2006-10-12

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

aorta valve stenosis leaking heart valve

Interventions

Via enterance by the arteria femoralis and a single valvuloplasty the delivery catheter with the prosthesis will be implanted over the native aortic valve, by controlled echo and fluoroscopy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: significant aortic valve stenosis, euroscore higher than 15 and/or age higher than 75 years

Exclusion criteria

Exclusion criteria: previous aortic valve replacement, recent or evalutive CVA, kreatine clearance less than 20ml per minute, mitral and tricuspid insuffiency more than grade 2

Design outcomes

Primary

Measure	Time frame
· Performance is defined by device functionality based on the investigator evaluation rating on the system and the procedure success rate at discharge defined as a correct prosthesis valve function without any major adverse event (MAE) at discharge (or 10 days whichever occurs first) · Safety is defined as clinical outcome (composite of MAE including major adverse cardiac events) at discharge and 30 days.	—

Measure

Time frame

· Performance is defined by device functionality based on the investigator evaluation rating on the system and the procedure success rate at discharge defined as a correct prosthesis valve function without any major adverse event (MAE) at discharge (or 10 days whichever occurs first) · Safety is defined as clinical outcome (composite of MAE including major adverse cardiac events) at discharge and 30 days.

—

Secondary

Measure	Time frame
· Clinical : patient functional status (NYHA) from discharge until 48 month follow-up, patient neurological status (NIH stroke scale) from discharge to 6 month follow-up. MAE from 3 month to 48 month follow-up · Performance: valve performance , valve migration, paravalvular leak assessed by Doppler echocardiography from 1 to 48 month follow-up,	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)