Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Not applicable

Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis

NCT03972644 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2020-01-01
Last updated
2020-09-14

Condition(s) studied

Aortic Valve StenosisDiastolic Dysfunction

Investigational drug(s) / intervention(s)

Aortic valve replacement

Aortic valve replacement: Open heart surgery or transcatheter surgery

Study summary

The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. Severe AS defined as 1. aortic valve area (AVA) ≤1 cm2, AND 2. Transvalvular maximum velocity (Vmax) ≥3.5 m/s AND 3. AS severity evaluated severe by a heart valve team conference. In cases where severity is not unambiguous an integrative approach will be utilized combining echocardiographic markers of valve severity and LV function, and if necessary aortic valve calcification estimated by non-contrast CT. 2\. Considered to be asymptomatic (estimated by a consultant in cardiology) 3. Considered to be candidate for AVR (transcatheter AVR/surgical AVR) 4. Sign of increased LV filling pressures18 or reduced longitudinal LV systolic function <!-- --> 1. Left atrial volume index (LAVi) \> 34 ml/m2; OR 2. ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e') ratio E/e'avg\>13; OR 3. Threefold elevation in NT-proBNP compared to the upper expected age and gender value. OR 4. GLS\>-15 5. Age ≥18 years 6. Signed informed consent Exclusion Criteria: 1. LVEF\<50% 2. Very severe AS defined as Vmax\>5 m/s. 3. Concomitant severe valvular disease other than AS 4. Previous valvular surgery 5. Estimated glomerular filtration rate\<30 ml/min/m2 6. Dementia 7. Women of childbearing potential 8. Inability to provide informed consent 9. Age\>85 years. 10. Supravalvular or subvalvular AS

Primary outcome measure(s)

  • all-cause mortality — After 379 events (approx 5 years)
    All-cause mortality assessed by Danish patient records

Trial sites (1)

FacilityCityRegionStatus
Odense University Hospital Odense Fyn Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03972644 on ClinicalTrials.gov ↗ ← All trials in Denmark