Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03247465 |
Other study ID # |
RC17_0114 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 13, 2017 |
Est. completion date |
September 13, 2017 |
Study information
Verified date |
September 2021 |
Source |
Nantes University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Aortic stenosis is one of the most common cardiology diseases. Trans aortic valve
implantation (TAVI) has been developed since 2002, first to treat rejected patients from
conventional surgery, then to treat high surgical risk patients and nowadays probably
intermediate surgical risk patient. TAVI related complications are still recurrent and the
investigators are searching a way to decrease them.
One of them could be image fusion, since it may decrease radiation exposure and contrast
agent use. It may also improve valve placement position leading to decreased complications.
40 prospective and consecutive patients will be included. Participants will be divided into
two groups: the 20 first included will be control group, the 20 following patients will be
the fusion group. For control group TAVI procedure will be the usual one, for fusion group
the procedure will be the usual one with addition of computed tomography 3D images fusion
with fluoroscopy 2D images.
Main evaluation criteria will be radiation exposure, measured by dose area product (DAP).
Secondary evaluation criterion will be procedural as contrast agent volume used, procedure
duration, subjective usefulness of image fusion or procedure failure evaluated immediately
after procedure. The investigators will also evaluated procedure induced complications as de
novo pacemaker implantation, de novo left bundle branch, vascular complication, major
bleeding, acute kidney failure, significant aortic regurgitation. These complications
occurrence will be evaluated after 1 month follow up, during the usual following
consultation.
Description:
Aortic stenosis is one of the most common cardiology diseases. If untreated, symptomatic
aortic stenosis rapidly leads to death. Most of the time, this disease affects old fragile
people for whom conventional surgery is countered or very risky. That is why Trans aortic
valve implantation has been developed since 2002, first to treat rejected patients from
conventional surgery, then to treat high surgical risk patients and nowadays probably
intermediate surgical risk patient. Indeed, thanks to prodigious technical and human
progress, procedure induced complication have clearly decreased. But TAVI related
complications are still recurrent and the investigators are searching a way to decrease them.
One of them could be image fusion, since it may decrease radiation exposure and contrast
agent use correlated to acute kidney failure. It may also improve valve placement position,
and the investigators know that many rhythmic (atrio-ventricular block) and valvular
(significant aortic regurgitation) complications are partially due to placement mistakes. So
the investigators hope that image fusion will decrease these complications.
The investigators will include 40 prospective and consecutive patients. Inclusion criterion
will be all major patients admitted in Nantes CHU for transfemoral aortic valve replacement
with SAPIEN® 3 valve. Exclusion criterion will be women of childbearing age without
contraception, impossible written consent, judiciary protected people. After inclusion,
patients will be divided into two groups: the 20 first included will be control group, the 20
following patients will be the fusion group. For control group TAVI procedure will be the
usual one, for fusion group the procedure will be the usual one with addition of computed
tomography 3D images fusion with fluoroscopy 2D images. The only difference during all
patient medical care will be the addition of image fusion in fusion group. Before and after
procedure, both groups will have the usual medical monitoring and the appropriated medical
interventions to participants case.
Main evaluation criterion will be radiation exposure, measured by dose area product (DAP).
Secondary evaluation criterion will be procedural as:
- contrast agent volume used (mL),
- procedure duration (min),
- subjective usefulness of image fusion evaluated on a 0 to 3 scale
- procedure failure : death, more than one valve implantation, valve dysfunction (mean
trans-valvular gradient > 20 mmHg or moderate to severe aortic regurgitation) These
criterions will be evaluated immediately after procedure.
The investigators will also evaluated procedure induced complications as:
- de novo pacemaker implantation
- de novo left bundle branch
- non minor vascular complication on VARC-2 definition
- major bleeding (BARC 3 or 5)
- acute kidney failure (AKIN 2 or 3)
- significant aortic regurgitation ≥ 2/4 These complications occurrence will be evaluated
after 1 month follow up, during the usual following consultation with echocardiography.
Then differences between will be tested with appropriated statistical methods.