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

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT01991444
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief 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

Detailed Description

Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

Study Timeline

• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Study Start: 2014-02
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comprehensive geriatric assessment	Baseline and 3 months	Demonstrate CGA changes within 3 months after TAVI; The CGA is an array of several different assessments with regard to frailty, comorbidities, administrative data (Silver code), Quality of life etc. Every Patient will undergo a CGA at baseline and 3 months after TAVI. Data will be analyzed to determine changes in CGA results.

Secondary Outcome Measures

Name	Time	Method
Score development	after 3 months	Development of a comprehensive score for the assessment of TAVI patient prognosis (identifying variables from the MPI, SPPB and SilverCode that account for 80% of the predictive power of the complete set)
predictive Value of CGA Tavi	baseline	Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission

Trial Locations

Locations (3)

CRCHUM Montréal; 🇨🇦 Montreal, Canada

University Medical Center; 🇮🇹 Florence, Italy

Academisch Medisch Center; 🇳🇱 Amsterdam, Netherlands