Structural Integrity of the Medtronic Corevalve System after Transcatheter Aortic Valve Implantation

Structural Integrity of the Medtronic Corevalve System after Transcatheter Aortic Valve Implantation - TACT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38983

Enrollment

Registered

2013-12-04

Start date

2014-08-12

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

corevalve function deformation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who underwent TAVI at least 4 years earlier will be approached by telephone to ask for participation in this study. Afterwards a formal invitation letter will be sent out.

Exclusion criteria

Exclusion criteria: 1) GFR

Design outcomes

Primary

Measure	Time frame
- TTE, MSCT and Rotational Angiography protocols are used to assess o Identify fractures in the MCS framework o Determine diameter of MCS inflow, outflow and valve functioning segment and assess circularity o Determine changes in diameters with previous follow up MSCT/rotational angiography when available o Determine Inflow and constraint segment perimeter and area o Depth of implantation/evidence for Corevalve migration over time	—

Measure

Time frame

- TTE, MSCT and Rotational Angiography protocols are used to assess o Identify fractures in the MCS framework o Determine diameter of MCS inflow, outflow and valve functioning segment and assess circularity o Determine changes in diameters with previous follow up MSCT/rotational angiography when available o Determine Inflow and constraint segment perimeter and area o Depth of implantation/evidence for Corevalve migration over time

—

Secondary

Measure	Time frame
o Transprosthetic gradient as assessed by Doppler TTE o Progression of (paravalvular) aortic regurgitation by Doppler TTE o Assess LV diameters/volumes o Changes in the parameters above over time	—

Countries

Netherlands

Outcome results