NCT03972644

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,700

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jan 2020

Longer than P75 for not_applicable

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

Study Progress66%
Jan 2020Sep 2029

First Submitted

Initial submission to the registry

May 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

9.7 years

First QC Date

May 31, 2019

Last Update Submit

September 9, 2020

Conditions

Aortic Valve StenosisDiastolic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    All-cause mortality assessed by Danish patient records

    After 379 events (approx 5 years)

Secondary Outcomes (3)

  • Combined endpoint

    After 379 events (approx 5 years)

  • all-cause mortality in patients with low-gradient AS

    After 379 events (approx 5 years)

  • Combined endpoint in low-gradient AS

    After 379 events (approx 5 years)

Other Outcomes (5)

  • Pericardiocentesis

    5 years

  • sternal infection

    5 years

  • Persistent renal failure

    5 years

  • +2 more other outcomes

Study Arms (2)

Early intervention

ACTIVE COMPARATOR

Patients will undergo aortic valve replacement immediately

Procedure: Aortic valve replacement

Watchfull waiting

NO INTERVENTION

Patients will be followed and treated as recommended by guidelines.

Interventions

Aortic valve replacementPROCEDURE

Open heart surgery or transcatheter surgery

Early intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Severe AS defined as
  • aortic valve area (AVA) ≤1 cm2, AND
  • Transvalvular maximum velocity (Vmax) ≥3.5 m/s AND
  • 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.
  • \. 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
  • <!-- -->
  • Left atrial volume index (LAVi) \> 34 ml/m2; OR
  • ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e') ratio E/e'avg\>13; OR
  • Threefold elevation in NT-proBNP compared to the upper expected age and gender value. OR
  • GLS\>-15 5. Age ≥18 years 6. Signed informed consent

You may not qualify if:

  • LVEF\<50%
  • Very severe AS defined as Vmax\>5 m/s.
  • Concomitant severe valvular disease other than AS
  • Previous valvular surgery
  • Estimated glomerular filtration rate\<30 ml/min/m2
  • Dementia
  • Women of childbearing potential
  • Inability to provide informed consent
  • Age\>85 years.
  • Supravalvular or subvalvular AS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

RECRUITING

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

Central Study Contacts

Jordi S Dahl, MD, PhD

CONTACT

+4523823016jordi.dahl@rsyd.dk

Jacob E Møller, MD, PhD

CONTACT

jem@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, Ph.D.

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 3, 2019

Study Start

January 1, 2020

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)