Early Surgery for Patients With Asymptomatic Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

— ESTIMATE  

Official title:

Early Surgery for Patients With Asymptomatic Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627391
• Other study ID #: AOM 140460
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2015
• Last updated: July 3, 2017
• Start date: January 2016
• Est. completion date: November 2019

Study information

• Verified date: June 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-Luc MONIN, MD PhD.
• Phone: (0)1 49 81 28 10
• Email: jean-luc.monin[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Aortic Valve Surgery
• Constriction, Pathologic

Intervention

Other:
• Early surgical aortic valve replacement

• Delayed Surgical aortic valve replacement

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

Farré N, Gómez M, Molina L, Cladellas M, Blé M, Roqueta C, Ascoeta MS, Comin-Colet J, Vila J, Bruguera J. Prognostic value of NT-proBNP and an adapted monin score in patients with asymptomatic aortic stenosis. Rev Esp Cardiol (Engl Ed). 2014 Jan;67(1):52-7. doi: 10.1016/j.rec.2013.06.020. Epub 2013 Oct 20. — View Citation

Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS), Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schäfers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012 Oct;33(19):2451-96. doi: 10.1093/eurheartj/ehs109. Epub 2012 Aug 24. — View Citation

Monin JL, Lancellotti P, Monchi M, Lim P, Weiss E, Piérard L, Guéret P. Risk score for predicting outcome in patients with asymptomatic aortic stenosis. Circulation. 2009 Jul 7;120(1):69-75. doi: 10.1161/CIRCULATIONAHA.108.808857. Epub 2009 Jun 22. — View Citation

Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. Erratum in: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text. — View Citation

Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combination of overall mortality and cardiac morbidity	Any adverse cardiac event requiring hospitalization. Adverse cardiac events include: 1/ development of any symptom clearly related to AS (dyspnea, angina, pre-syncope or syncope during exercise); 2/ major adverse cardiac events defined as congestive heart failure or acute coronary syndrome; 3/ death of any cause, including cardiac death.	1 year after randomization.
Secondary	Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity		1 year after randomization
Secondary	Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group		assessed at 3 months after surgery
Secondary	Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group		assessed at 3 months after surgery
Secondary	Postoperative Exercise test (Exercise Electrocardiogram)		assessed at 3 months after surgery