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

Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: TAVI

Detailed Description

Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada, H2X 0A9
    • CRCHUM Montréal
• Italy
  • Florence, Italy
    • University Medical Center
• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites.

Routine data about the invervention (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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

TAVI patients of > 79 years; 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.

Other: TAVI; no Intervention planned, Observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Principal Investigator: Andrea Ungar, MD, Geriatric Cardiology and Medicine - U. of Florence

Publications and helpful links

General Publications

• Ungar A, Mannarino G, van der Velde N, Baan J, Thibodeau MP, Masson JB, Santoro G, van Mourik M, Jansen S, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Maggi S, Schoenenberger AW. Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry. BMC Cardiovasc Disord. 2018 Jan 4;18(1):1. doi: 10.1186/s12872-017-0740-x.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: U1111-1149-9951; DRKS00005436 (Other Identifier: Deutsches Register für Klinische Studien)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED