Overview

This trial is active, not recruiting.

Condition aortic valve stenosis
Treatment tavi
Sponsor Institut für Pharmakologie und Präventive Medizin
Start date February 2014
End date July 2016
Trial size 72 participants
Trial identifier NCT01991444, DRKS00005436, U1111-1149-9951

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
tavi
no Intervention planned, Observation only

Primary Outcomes

Measure
Comprehensive geriatric assessment
time frame: Baseline and 3 months

Secondary Outcomes

Measure
predictive Value of CGA Tavi
time frame: baseline
Score development
time frame: after 3 months

Eligibility Criteria

Male or female participants at least 80 years old.

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

Additional Information

Official title Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.
Principal investigator Andrea Ungar, MD
Description Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Institut für Pharmakologie und Präventive Medizin.