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Status unknownNCT02627391ESTIMATEUpdated Jul 5, 2017

Early Surgery for Patients With Asymptomatic Aortic Stenosis

An interventional study of Early surgical aortic valve replacement and Delayed Surgical aortic valve replacement in Aortic Valve Stenosis and Aortic Valve Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-05.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Valve Stenosis
  • Aortic Valve Surgery

Keywords

  • Aortic valve
  • Stenosis
  • Surgery
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 360 is above the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    Early surgery

    Surgical aortic valve replacement

    Other: Early surgical aortic valve replacement

  • Active comparator
    Delayed surgery according to guidelines

    Surgical aortic valve replacement

    Other: Delayed Surgical aortic valve replacement

Interventions

  • OtherEarly surgical aortic valve replacement
  • OtherDelayed Surgical aortic valve replacement
06

What researchers measure

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.

    Time frame: 1 year after randomization.

Secondary outcomes

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

    Time frame: 1 year after randomization

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

    Time frame: assessed at 3 months after surgery

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

    Time frame: assessed at 3 months after surgery

  4. Postoperative Exercise test (Exercise Electrocardiogram)

    Time frame: assessed at 3 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Henri Mondor Hospital
    Creteil, 94010, France
    Recruiting
08

References and documents

Publications

  • 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. PubMed 19546391 ↗
  • 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. PubMed 24774264 ↗
  • 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. Erratum In: J Am Coll Cardiol. 2014 Jun 10;63(22):2489. Dosage error in article text. PubMed 24603191 ↗
  • 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. PubMed 22922415 ↗
  • 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. PubMed 10403851 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02627391
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 10, 2015
Start date
Jan 2016
Primary completion
Nov 2018 (estimated)
Completion
Nov 2019 (estimated)
Last update
Jul 5, 2017

Study contacts

Jean-Luc MONIN, MD PhD.
Contact
jean-luc.monin@aphp.fr
(0)1 49 81 28 10 ext. +33
Jean-Luc MONIN, MD PhD.
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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