In this study we want to assess the structural THV integrity in situ and to identify the respective accommodation patterns of the different THV platforms and the interaction with the aortic root in situ.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary Objective:
o Transprosthetic gradient as assessed by Doppler TTE
o (paravalvular) aortic regurgitation by Doppler TTE
o Assess LV diameters/volumes
Background summary
Knowledge about in-situ Transcatheter Heart Valve (THV) appearance and
structural integrity of the THV after implantation may provide insights in
valve performance and durability. The aortic root can become circular or the
THV can become ellipsoid. The impact on the long term is currently unsettled
and requires extended follow up. Circularity of aortic annulus is defined using
the eccentricity index (1 - Dmin/Dmax).
Study objective
In this study we want to assess the structural THV integrity in situ and to
identify the respective accommodation patterns of the different THV platforms
and the interaction with the aortic root in situ.
Study design
Two-center prospective observational study: Erasmus MC and Amphia Breda.
Study burden and risks
Eligible patients who consent to participate in the CONTACT study will be
invited for an additional MSCT scan and rotational angiography on top of the
regular 6-month follow up at the outpatient clinic.
The major issue would be the exposure to clinical radiation. Yet, in this set
of elderly patients with a limited life expectance, the clinical risks
associated with radiation exposure will be negligible. Furthermore contrast
exposure is limited to patients with a GFR > 40 mL/min. Pre- and posthydration
protocols are scheduled for patients with GFR between 40 and 60 mL/min to
prevent contrast induced nephropathy. The rotational angiography in the cathlab
will evolve without contrast.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
1) GFR < 40 mL/min
2) No written informed consent
3) Previous stroke with residual neurological symptoms or dementia
4) Not native Dutch speaking
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48123.078.14 |