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

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Other: TAVI

• 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

Arm && Interventions

Group	Intervention	Description
TAVI patients of > 79 years	TAVI	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.

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