To evaluate the safety & efficacy of automatic valve plane tracking for the deployment of transcatheter bioprostheses.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Volume of contrast.
- Valve deployment time.
- Depth of implantation of the valve (non-coronary and left aortic sinus) in mm
based upon contrast angiography after valve deployment.
Secondary outcome
- Mortality within the hospital or at 30 days whichever comes first.
- Renal insufficiency.
- Paravalvular aortic regurgitation.
Background summary
Transcatheter Aortic Valve Implantation (TAVI) is increasingly being used for
patients with aortic stenosis who are ineligible or too high risk for surgical
valve replacement (AVR). At variance with AVR, TAVI concerns catheter-based
treatment on the beating heart without direct visualization of the target zone.
For proper valve positioning, visualization of the base of the aortic root is
done by fluoroscopy and contrast angiography with or without transesophageal
echocardiography.
Correct positioning is mandatory for reasons of safety and efficacy in addition
to the performance or execution of TAVI. It is conceivable that advanced
imaging may be associated with increased safety and performance by * among
others * less use of contrast, more correct final valve position and shorter
procedure time. For that purpose, software has been developed that offers
on-line continuous definition of the base of the aortic root by a single line
connecting the nadir of the three aortic sinuses depicted on the X ray screen
during TAVI. In the present study we seek to investigate the acute benefits of
such software.
Study objective
To evaluate the safety & efficacy of automatic valve plane tracking for the
deployment of transcatheter bioprostheses.
Study design
Randomized open-label single-center pilot study.
Intervention
Not applicable.
Study burden and risks
Hypothetical benefits are reduction of the use of contrast during the procedure
- with a subsequent lower rate of renal insufficiency - reduction of the
procedure time through a reduction of the time of deployment and improving of
the level of implantation.
As in any TAVI procedure, a risk is the misdeployment of the prosthesis.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Subject is * 18 years of age.
2. Subject is eligible for TAVI with a a CE approved transcatheter heart valve.
3. Subject understands the study requirements and the treatment procedures, and provides written informed consent.
4. Subject is capable of returning to the study hospital for all required follow-up.
Exclusion criteria
1. The aortic root cannot be defined by the software.
2. Subject did not receive a valve because of aborted procedure.
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 | NL48323.078.14 |