Early Surgery for Patients With Asymptomatic Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-11-30

Brief Summary

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Many cardiologists are convinced that early surgery in asymptomatic aortic stenosis (AS) saves lives. However there is currently no direct evidence for this and most recommendations from the ESC/ EACTS or ACC/ AHA in this field are supported by Level-B or C evidence. Therefore, the investigators designed a randomized controlled trial to demonstrate whether early surgery improves mortality and morbidity of patients with asymptomatic severe AS and low operative risk.

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Detailed Description

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Conditions

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Aortic Valve Stenosis Aortic Valve Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Early surgery

Surgical aortic valve replacement

Group Type EXPERIMENTAL

Early surgical aortic valve replacement

Intervention Type OTHER

Delayed surgery according to guidelines

Surgical aortic valve replacement

Group Type ACTIVE_COMPARATOR

Delayed Surgical aortic valve replacement

Intervention Type OTHER

Interventions

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Early surgical aortic valve replacement

Intervention Type OTHER

Delayed Surgical aortic valve replacement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patient, aged between 18 and 80 years (18 ≤ age ≤80)
* Low operative risk, defined as EuroSCORE II ≤ 5%
* No symptom potentially attributable to AS: no dyspnea, angina or syncope during exercise
* No class I indication for surgery
* No symptom/ fall in blood pressure during exercise test
* Severe AS according to current echocardiography criteria: Vmax \> 4.0 m/s and/ or MPG \> 40 mm Hg); AVA \< 1.0 cm2 (not mandatory)
* Preserved LV systolic function: LVEF \>50% according to echocardiography ; no LV wall motion abnormality
* Signed informed consent

Exclusion Criteria

* Moderate/ high operative risk for aortic valve replacement, defined as EuroSCORE II \> 5%
* Class-I indication for AVR (ESC-EACTS 2012, ACC/ AHA 2014) or fall in blood pressure during exercise testing (Class-IIa)
* Other indication for cardiac surgery (CABG, thoracic aorta)
* Positive exercise test including A/ unmasking of symptoms (angina, dyspnea at low workload, dizziness or syncope) during exercise or B/ Fall in systolic blood pressure during exercise below the baseline value.
* Patients unable to perform the exercise ECG
* More than mild AR (\>grade 2/4)/ other significant valve disease LVEF ≤ 50%
* Serum creatinine \>160 μmol/L
* Serious extra cardiac comorbidity/ life expectancy \<2 years
* Patient included in another trial with signed informed consent
* Patient not affiliated to social insurance
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No