NCT01852552

Brief Summary

Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR). The objectives of the study are:

  1. 1.Description of neurocognitive status before and after transcatheter aortic valve implantation and aortic valve replacement procedures
  2. 2.Description of Quality of Life (QoL) after these procedures
  3. 3.Defining the relevance of baseline psychological, emotional and cognitive factors on the outcomes associated to the different treatment modalities
  4. 4.Assessment of costs associated to each of the above mentioned strategies of treatment, including costs of the index hospitalization and costs of follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

4.1 years

First QC Date

May 8, 2013

Last Update Submit

November 11, 2016

Conditions

Aortic Valve Stenosis

Keywords

Aortic stenosisTranscatheter aortic valve implantationAortic valve replacementCostsCognitive functionQuality of life

Outcome Measures

Primary Outcomes (4)

  • Mini Mental State Examination (MMSE)

    Changes in cognitive function after transcatheter aortic valve implantation and surgical aortic valve replacement

    baseline, 3-month, 12-month

  • Hospital Anxiety and Depression Scale (HADS)

    Changes of emotional status after transcatheter aortic valve implantation and surgical aortic valve replacement

    baseline, 3-month, 12-month

  • Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Changes in quality of life after transcatheter aortic valve implantation and surgical aortic valve replacement

    baseline, 3-month, 12-month

  • In-hospital costs

    Calculation of precise hospital costs for transcatheter aortic valve implantation and surgical Aortic Valve Replacement, including costs of hospitalization, drugs and devices.

    Participants will be followed for the duration of hospital stay, an expected average of 10 days for transcatheter aortic valve implantation and 2 weeks for surgical Aortic Valve Replacement

Secondary Outcomes (7)

  • Myocardial infarction

    30-day, 12-month and up to 2-year (longest available follow-up)

  • Stroke

    30-day, 12-month and up to 2-year (longest available follow-up)

  • Pace-maker implantation

    30-day, 12-month

  • Vascular complications

    30-day

  • Bleedings

    30-day

  • +2 more secondary outcomes

Study Arms (2)

Transcatheter aortic valve implantation

All consecutive patients undergoing TAVI at participating centres during study period

Device: transcatheter aortic valve implantation

Aortic Valve Replacement

All consecutive patients aged ≥ 80 years or with Logistic Euroscore≥ 15% undergoing AVR for AS at participating centers during the period of enrollment

Procedure: Aortic Valve Replacement

Interventions

transcatheter aortic valve implantationDEVICE

Patients undergoing TAVI with transfemoral, transapical, or any other vascular access

Also known as: Edwards Sapien XT, Corevalve, Acurate-TA
Transcatheter aortic valve implantation
Aortic Valve ReplacementPROCEDURE

Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)

Aortic Valve Replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients undergoing TAVI or AVR for AS at participating centers during the period of enrollment

You may qualify if:

  • All consecutive patients undergoing TAVI at participating centers during the period of enrollment
  • All consecutive patients aged ≥80 years or with Logistic Euroscore ≥15% undergoing AVR at participating centers during the period of enrollment

You may not qualify if:

  • Absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 13, 2013

Study Start

December 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

IT(1)