NCT03583398

Brief Summary

The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and surgical aortic valve replacement (SAVR).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

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

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

June 28, 2018

Last Update Submit

July 11, 2018

Conditions

Quality of Life

Keywords

TAVIquality of lifeSAVR

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life: EQ-5D-3L questionnaire

    EQ-5D-3L questionnaire

    1 month and 1 year follow-up

Study Arms (3)

TAVI TAo

Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement

TAVI TF

Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement

AVR

Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement

Interventions

transcatheter aortic valve implantation, surgical aortic valve replacementPROCEDURE

Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.

AVRTAVI TAoTAVI TF

Eligibility Criteria

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

Elderly population with aortic valve stenosis.

You may qualify if:

  • aortic valve stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, Psychologist

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 11, 2018

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

July 12, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share