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

NCT01991444 | Completed

• 2 other identifiers: U1111-1149-9951DRKS00005436
• Study Type: observational
• Target: 72
• Locations: 3 countries
• Sites: 3

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

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• predictive Value of CGA Tavi

  baseline

• Score development

  after 3 months

Study Arms (1)

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

Interventions

TAVI OTHER

no Intervention planned, Observation only

TAVI patients of > 79 years

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Presence of contraindications as to the Instructions for Use
• No possibility for a follow-up

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (3)

CRCHUM Montréal

Montreal, H2X 0A9, Canada

Location

University Medical Center

Florence, Italy

Location

Academisch Medisch Center

Amsterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 29301486 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Andrea Ungar, MD

  Geriatric Cardiology and Medicine - U. of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 25, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

CA (1); IT (1); NL (1)