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

Aortic Valve Stenosis Clinical Trial

— CGA-TAVI  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991444
• Other study ID #: U1111-1149-9951
• Secondary ID: DRKS00005436
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: April 4, 2017
• Start date: February 2014
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Other:
• TAVI
no Intervention planned, Observation only

Locations

Country	Name	City	State
Canada	CRCHUM Montréal	Montreal
Italy	University Medical Center	Florence
Netherlands	Academisch Medisch Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin

Countries where clinical trial is conducted

Canada,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehensive geriatric assessment	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.	Baseline and 3 months
Secondary	predictive Value of CGA Tavi	Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission	baseline
Secondary	Score development	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)	after 3 months