Knowledge about long-term structural integrity of the MCS may support the current trends to expand TAVI technology to lower risk patient populations with longer life expectancy.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 outcome
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
Background summary
Symptomatic severe aortic valve stenosis (AS) has a dismal prognosis.
Surgical aortic valve replacement (SAVR) is the standard treatment of care.
The first Transcatheter aortic valve implantation (TAVI) for the treatment of
AS was conducted in 2002.
The Tavi technology is reserved for patients with severe AS and a (very) high
surgical risk.
From trans-thoracic ultrasound after 2 years it becomes clear that at very high
risk patients, the implantation of the TAVI has been very successful.
In the long term, the durability of the transcatheter system has to be
demonstrated by evaluating the overall integrity of the system before to fit in
patients with lower risk and longer life expectacy.
MSCT scan, transthoracal echo and rotational angiography may serve to evaluate
the structural integrity by looking at stent fractures, expansion and
eccentricity after four years
Study objective
Knowledge about long-term structural integrity of the MCS may support the
current trends to expand TAVI technology to lower risk patient populations with
longer life expectancy.
Study design
This is a single center study. Patients will be invited to the Thoraxcenter for
a one-day visit to undergo 1) transthoracic echocardiography; 2) MSCT scan
(without contrast); 3) Rotational Angiography.
Previous follow up TTE and MSCT will be used for comparison whenever available.
Survival status will be confirmed in the Civil Registry. Prof. Dr. de Jaegere
will call the patients personally and explain the study design. If the patient
agrees to participate, a patient information form including a consent form will
be sent to the patient*s home address. After the patient will have sent back
the signed informed consent form, the patient becomes eligible for the study
and will be invited for a visit to the Thorax Center.
Study burden and risks
not applicable
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
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 | NL45502.078.13 |