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Early Surgery for Patients With Asymptomatic Aortic Stenosis (ESTIMATE)

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ClinicalTrials.gov Identifier: NCT02627391
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Aortic Valve Surgery Other: Early surgical aortic valve replacement Other: Delayed Surgical aortic valve replacement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Early Surgery for Patients With Asymptomatic Aortic Stenosis
Actual Study Start Date : January 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Combination of overall mortality and cardiac morbidity [ Time Frame: 1 year after randomization. ]
    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.


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627391


Contacts
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Contact: Jean-Luc MONIN, MD PhD. (0)1 49 81 28 10 ext +33 jean-luc.monin@aphp.fr

Locations
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France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Jean-Luc MONIN, MD PhD    (0)1 49 81 28 10 ext +33    jean-luc.monin@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Luc MONIN, MD PhD. Assistance Publique - Hôpitaux de Paris

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02627391     History of Changes
Other Study ID Numbers: AOM 140460
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Aortic valve
Stenosis
Surgery

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction