Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
Key facts
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Where
- Switzerland3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 17 Aug 2022
- Expected to end
- 1 Jan 2030
- Type of study
- Interventional, 2 groups
- Treatments tested
- Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement
- Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
- Record updated
- 21 November 2023
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Age ≥18 years
- Moderate native aortic stenosis defined by an aortic valve area (AVA) ≤1.5 cm2 and >1.0 cm2 and transvalvular mean gradient ≥20 mmHg and <40 mmHg
- Primary or secondary mitral regurgitation (at least moderate) defined by effective regurgitant orifice area (EROA) ≥20 mm2 or regurgitant volume ≥30 ml
- New York Heart Association (NYHA) functional class ≥2
Who cannot take part
- Transcatheter or surgical treatment of valvular and/or coronary artery disease within 90 days prior to randomization
- COPD with home oxygen therapy
- Stroke within 30 days prior to the randomization
- Life expectancy <1 year irrespective of valvular heart disease
- Severe tricuspid valve disease requiring intervention
- Patients with severe secondary MR who remain symptomatic despite optimal medical therapy and who are judged appropriate for transcatheter edge-to-edge repair or surgery by the Heart Team
- Left ventricular ejection fraction <30% or LVESD >70mm
- Echocardiographic evidence of severe right ventricular dysfunction
- Untreated clinically significant CAD requiring revascularisation
- Moderate or severe aortic regurgitation
- Symptomatic patients with severe primary MR who are operable and not high risk
- Estimated or measured systolic PAP >70 mmHg
- Inability to provide written informed consent
- Participation in another cardiovascular trial before reaching the primary endpoint
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
The 2 groups in the trial
- Early transcatheter or surgical aortic valve replacementTreatment being tested
Early transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement.
Treatment: Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement
- Control InterventionOther group
Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention.
Treatment: Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation: a Randomized Clinical Trial
- Record updated
- 21 November 2023