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Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis (RECOVERY)

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ClinicalTrials.gov Identifier: NCT01161732
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Korea Institute of Medicine
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE July 12, 2010
First Posted Date  ICMJE July 14, 2010
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE July 2010
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
  • Cardiac mortality [ Time Frame: Entire follow-up ( a minimum of 4 years) ]
    defined as death from complications of myocardial infarction, heart failure, shock, complications of cardiac surgery or intervention, other cardiovascular diseases including sudden cardiac death
  • Operative mortality [ Time Frame: up to 30 days after surgery ]
    Operative mortality is defined as death within 30 days of surgery.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • Cardiac mortality [ Time Frame: up to 4 years after enrollment ]
  • Operative mortality [ Time Frame: up to 30 days after surgery ]
    Operative mortality is defined as death within 30 days of surgery.
Change History Complete list of historical versions of study NCT01161732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
  • All-cause death [ Time Frame: Entire follow-up (a minimum of 4 years) ]
  • Repeat aortic valve surgery [ Time Frame: Entire follow-up (a minimum of 4 years) ]
  • Clinical thromboembolic events [ Time Frame: Entire follow-up (a minimum of 4 years) ]
    Diagnosis of thromboembolic events is based on clinical symptoms, signs and imaging studies.
  • Hospitalization due to congestive heart failure [ Time Frame: Entire follow-up (a minimum of 4 years) ]
    A hospitalization due to congestive heart failure is defined as an unplanned, urgent admission for the management of congestive heart failure.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2010)
  • All-cause death [ Time Frame: up to 4 years after enrollment ]
  • Repeat aortic valve surgery [ Time Frame: up to 4 years after enrollment ]
  • Clinical thromboembolic events [ Time Frame: up to 4 years after enrollment ]
    Diagnosis of thromboembolic events is based on clinical symptoms, signs and imaging studies.
  • Hospitalization due to congestive heart failure [ Time Frame: up to 4 years after enrollment ]
    A hospitalization due to congestive heart failure is defined as an unplanned, urgent admission for the management of congestive heart failure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
Official Title  ICMJE Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
Brief Summary The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of early surgery with those of conventional treatment strategy in a prospective randomized trial.
Detailed Description Management of asymptomatic patients with severe aortic stenosis (AS) remains controversial, and the combined risks of aortic valve surgery and late complications of aortic valve prosthesis need to be balanced against the possibility of preventing sudden death and lowering cardiac mortality. Considering that sudden cardiac death occurs at a rate of approximately 1% per year and that the average postoperative mortality of isolated AV replacement is 3.0-4.0%, the 2007 European Society of Cardiology guidelines do not recommend aortic valve surgery for asymptomatic patients with severe AS and the 2006 American College of Cardiology/American Heart Association guidelines recommend surgery as a class IIb indication only in patients with extremely severe AS and who are at low operative risk. Clinical outcomes vary widely according to the severity of stenosis in asymptomatic AS, and asymptomatic patients with very severe AS are often referred for aortic valve replacement in clinical practice despite the lack of data supporting early surgery. Rosenhek et al recently reported a worse prognosis with a higher event rate and a risk of rapid deterioration in very severe AS, and the investigators also recently reported that compared with the conventional treatment strategy, early surgery in patients with very severe AS is associated with an improved long-term survival in a prospective, observational study. However, there have been no prospective,randomized studies comparing early surgery with a watchful waiting strategy in very severe AS. We sought to compare long-term clinical outcomes of early surgery with those of conventional management based on current guidelines.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
early aortic valve replacement
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Stenosis
Intervention  ICMJE Procedure: Early surgery
Early surgery is performed within 2 months of randomization.
Other Name: Early aortic valve replacement surgery
Study Arms  ICMJE
  • No Intervention: Conventional treatment
    In the conventional treatment group, indications for aortic valve replacement surgery are development of symptoms, reduced left ventricular systolic function and an increase in aortic jet velocity > 0.5 m/sec during follow-up.
  • Active Comparator: Early Surgery
    Early surgery is performed within 2 months of randomization.
    Intervention: Procedure: Early surgery
Publications * Kang DH, Park SJ, Rim JH, Yun SC, Kim DH, Song JM, Choo SJ, Park SW, Song JK, Lee JW, Park PW. Early surgery versus conventional treatment in asymptomatic very severe aortic stenosis. Circulation. 2010 Apr 6;121(13):1502-9. doi: 10.1161/CIRCULATIONAHA.109.909903. Epub 2010 Mar 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2016)
145
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
144
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • asymptomatic patients with very severe aortic stenosis who are potential candidates for early surgery. Very severe aortic stenosis are defined as a critical stenosis in the AV area ≤ 0.75 square centimeter fulfilling one of the following criteria; a peak aortic velocity ≥ 4.5 m/sec or a mean transaortic pressure gradient ≥ 50 mmHg on Doppler echocardiography.

According to the revised 2014 AHA/ACC Valvular Heart Disease Guideline that recommends exercise testing to confirm the absence of symptoms in asymptomatic patients with severe AS (Class IIa), eligible patients with a positive exercise test will be excluded from the entry after May, 2014.

Exclusion Criteria:

  • Exertional dyspnea
  • Angina
  • Syncope
  • Left ventricular ejection fraction < 50%
  • Significant aortic regurgitation
  • Significant mitral valve disease
  • Pregnancy
  • Age < 20 years or > 80 years
  • Coexisting malignancies
  • Positive exercise test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01161732
Other Study ID Numbers  ICMJE 2010-0065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duk-Hyun Kang, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Korea Institute of Medicine
Investigators  ICMJE
Principal Investigator: Duk-Hyun Kang, M.D. Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine
PRS Account Asan Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP