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Valve Plane Tracking for TAVI; Automatic Valve plane tracking for Transcatheter Aortic Valve Implantation.

Valve Plane Tracking for TAVI; Automatic Valve plane tracking for Transcatheter Aortic Valve Implantation. - Valve Tracking

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40644
Enrollment
20
Registered
2014-08-11
Start date
Unknown
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

Aortic stenosis Aorticvalve stenosis

Interventions

Not applicable.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. The aortic root cannot be defined by the software. 2. Subject did not receive a valve because of aborted procedure.

Design outcomes

Primary

MeasureTime frame
- 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

MeasureTime frame
- Mortality within the hospital or at 30 days whichever comes first. - Renal insufficiency. - Paravalvular aortic regurgitation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)