COmparison of iN situ structural integrity of TrAnsCatheter Heart Valves

COmparison of iN situ structural integrity of TrAnsCatheter Heart Valves - CONTACT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40932

Enrollment

Registered

2014-06-10

Start date

2014-05-01

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

function and durability of aorticvalve Structural integrity of transcatheter heart valve

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All Patients who undergo TAVI with the following THV are eligible for this study: 1. Medtronic Corevalve 2. Edwards Sapien and Sapien 3 3. BSC Lotus 4. St Jude Portico 5. Jenavalve THV 6. Direct Flow

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) GFR

Design outcomes

Primary

Measure	Time frame
Primary Objective: MSCT and rotational angiography protocol is used to assess: o Identify fractures in the framework o Determine diameter of THV inflow, outflow and valve functioning segment and assess circularity o Determine Inflow and constraint segment perimeter and area o Aortic root -THV relationship: circularity index of aortic root and THV	—

Secondary

Measure	Time frame
Secondary Objective: o Transprosthetic gradient as assessed by Doppler TTE o (paravalvular) aortic regurgitation by Doppler TTE o Assess LV diameters/volumes	—

Countries

Netherlands

Outcome results