NCT02448485

Brief Summary

TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

May 15, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

10.3 years

First QC Date

May 15, 2015

Last Update Submit

July 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality (overall, cardiovascular)

    up to 8 years

Study Arms (2)

Aortic Valve Intervention

Consecutive symptomatic patients who underwent aortic valve intervention (SAVR or TAVI) for the treatment of severe AS since 2010

Procedure: Aortic Valve Intervention (surgical or transcatheter)

Conservative Treatment

Asymptomatic patients with aortic stenosis followed conservatively at our department

Interventions

Surgical or interventional aortic valve implantation

Aortic Valve Intervention

Eligibility Criteria

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

One patient cohort consists of patients with severe symptomatic aortic stenosis admitted for planned valve operation since 2010, when involved institutions started to routinely analyse hsTnT plasma levels. The other patient cohort consists of asymptomatic patients with aortic stenosis diagnosed treated conservatively.

You may qualify if:

  • aortic stenosis detected by echocardiography / invasively

You may not qualify if:

  • acute coronary syndrome
  • endocarditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisHeart FailureSyncopeAngina Pectoris

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaVascular DiseasesChest PainPain

Study Officials

  • Wolfgang Dichtl, MD, PhD

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Dichtl, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. DDr.

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 19, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations