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

Sponsor

Institut für Pharmakologie und Präventive Medizin (Other)

Overall Status

Completed

CT.gov ID

NCT01991444

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Other: TAVI

Detailed Description

Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

72 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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.

Actual Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

80 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CRCHUM Montréal	Montreal	Canada	H2X 0A9
2	University Medical Center	Florence	Italy
3	Academisch Medisch Center	Amsterdam	Netherlands

Sponsors and Collaborators

Institut für Pharmakologie und Präventive Medizin

Investigators

Principal Investigator: Andrea Ungar, MD, Geriatric Cardiology and Medicine - U. of Florence

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut für Pharmakologie und Präventive Medizin

ClinicalTrials.gov Identifier:

NCT01991444

Other Study ID Numbers:

U1111-1149-9951
DRKS00005436

First Posted:

Nov 25, 2013

Last Update Posted:

Apr 5, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Aortic Valve Stenosis

Study Results

No Results Posted as of Apr 5, 2017