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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991444
First Posted: November 25, 2013
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin
  Purpose

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 Intervention
Aortic Valve Stenosis Other: TAVI

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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.

Resource links provided by NLM:


Further study details as provided by Institut für Pharmakologie und Präventive Medizin:

Primary Outcome Measures:
  • Comprehensive geriatric assessment [ Time Frame: 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 [ Time Frame: baseline ]
    Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission

  • Score development [ Time Frame: 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)


Enrollment: 72
Actual Study Start Date: February 2014
Study Completion Date: February 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:
Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991444


Locations
Canada
CRCHUM Montréal
Montreal, Canada, H2X 0A9
Italy
University Medical Center
Florence, Italy
Netherlands
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
  More Information

Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT01991444     History of Changes
Other Study ID Numbers: U1111-1149-9951
DRKS00005436 ( Other Identifier: Deutsches Register für Klinische Studien )
First Submitted: November 7, 2013
First Posted: November 25, 2013
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction