CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes

Institut für Pharmakologie und Präventive Medizin

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Other: TAVI

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01991444

DRKS00005436 (Other Identifier)

U1111-1149-9951

Details and patient eligibility

About

Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation.

It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve Implantation in elderly ( > 80 years) Patient. Possible participants are all Patient of 80 years or above for whom the implantation of a Edwards Sapien XT aortic valve is planned

Full description

Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

Enrollment: 72 patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
• Compliance with the indications of the instructions for use
• Age of at least 80 years
• Written informed consent

Exclusion criteria

• Presence of contraindications as to the Instructions for Use
• No possibility for a follow-up

Trial design

72 participants in 1 patient group

TAVI patients of > 79 years

Description:

All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites. Routine data about the intervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected.

Treatment:

Other: TAVI