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Not yet recruitingNCT06255691AVR-10yearUpdated Feb 13, 2024

10-year Follow-up After Aortic Valve Replacement Surgery

An observational study in Aortic Stenosis, Anxiety and Depressive Symptoms, sponsored by Oslo University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
282
Ages
18 Years and older
Sex
All
01

Study summary

There is a lack of data on patients self-reported outcomes (PROMs) on health-related quality of life (HRQoL)and symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with the health services (PREMS). In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will repeat the survey on symtoms on anxiety and depresion using Hospital Anxiety and depression Scale (HADS), health-related quality of life (EQ-5D) and questions about experiences with the health services.

Read the detailed description

"The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre) was a prospective, randomized controlled study (RSC) Including 286 patients after AVR from 2015 til 2017, NCT02522663. The results reported in international publications showed reduced symptoms on anxiety the first month after AVR.

Reduction of anxiety revealed to be an important aim for the intervention. We found that symptoms of anxiety in the early rehabilitation phase after discharge following surgical aortic valve replacement phase was significantly reduced.

There is a lack of data on patients self-reported outcome on symptoms on anxiety and depression 10 years after Surgical After Aortic Valve Replacement (SAVR), and patient reported experiences with health services. In this 10-years follow-up study on patients alive from the study named "The Impact of 24/ 7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial (AVRre)" NCT02522663 we will conduct a survey on symtoms of anxiety and depresion using Hospital Anxiety and depression Scale (HADS), quality of life (EQ-5D) and questions about experiences with health services.

The results of the planned 10-years follow-up may give guidance in how to allocate health resources and planning for and follow-up of patients after heart surgery.

02

Conditions studied

  • Aortic Stenosis
  • Anxiety
  • Depressive Symptoms
  • Quality of Life

Keywords

  • aortic valve replacement
  • longitudinal study
  • patient reported outcome
  • symptoms of anxiety
  • health-related quality of life
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 282 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

10 year follow-up of the participants in the AVrRe study

Inclusion criteria

Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires

Exclusion criteria

-

Exclusion Criteria:

Patients not alive after the AVRre study

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
282 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Symptoms of anxiety and depression

    Symptoms of anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)

    Time frame: 10 year follow-up

  2. Health related quality of life

    EQ-5D-3L questionnaire from The EuroQol Group to measure health related quality of life.

    Time frame: 10 year follow-up

Secondary outcomes

  1. Experiences with health services

    Open questions

    Time frame: 10 year follow-up

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06255691
Lead sponsor
Oslo University Hospital
Collaborators
Oslo Metropolitan University
Responsible party
Stein Ove Danielsen (Associate professor, Oslo University Hospital) — Principal investigator
First posted
Feb 13, 2024
Start date
Apr 10, 2025 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Feb 13, 2024

Study contacts

Stein O Danielsen, PhD
Contact
steinove@oslomet.no
4741368255
Irene Lie, PhD
Contact
Irene.lie@ous-hf.no
99026729
Stein Ove O Danielsen, PhD
principal investigator · OsloMet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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