Early Surgery for Patients With Asymptomatic Aortic Stenosis

NCT02627391 | Unknown DMC

• 1 other identifier: AOM 140460
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis; Aortic Valve Surgery

Keywords

Aortic valve; Stenosis; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Each items of the composite criteria, overall and cardiovascular mortality and cardiac morbidity

  1 year after randomization

• Number of patients with preserved LV systolic function ( LVEF >50% according to echocardiography ) in each group

  assessed at 3 months after surgery

• Performance capacities assessed by speckle-tracking imaging (longitudinal function) in each group

  assessed at 3 months after surgery

• Postoperative Exercise test (Exercise Electrocardiogram)

  assessed at 3 months after surgery

Study Arms (2)

Early surgery

EXPERIMENTAL

Surgical aortic valve replacement

Other: Early surgical aortic valve replacement

Delayed surgery according to guidelines

ACTIVE COMPARATOR

Surgical aortic valve replacement

Other: Delayed Surgical aortic valve replacement

Interventions

Early surgical aortic valve replacement OTHER

Early surgery

Delayed Surgical aortic valve replacement OTHER

Delayed surgery according to guidelines

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

Related Publications (5)

• Monin JL, Lancellotti P, Monchi M, Lim P, Weiss E, Pierard L, Gueret 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.

  PMID: 19546391 BACKGROUND

• Farre N, Gomez M, Molina L, Cladellas M, Ble 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.

  PMID: 24774264 BACKGROUND

• 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. No abstract available.

  PMID: 24603191 BACKGROUND

• 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, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers 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. No abstract available.

  PMID: 22922415 BACKGROUND

• 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. doi: 10.1056/NEJM199907153410302.

  PMID: 10403851 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Luc MONIN, MD PhD.

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Luc MONIN, MD PhD.

CONTACT

(0)1 49 81 28 10; jean-luc.monin@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 10, 2015
• Study Start: January 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: July 5, 2017

Record last verified: 2017-06

Locations

FR (1)