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
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Condition or disease | Intervention/treatment | Phase |
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Aortic Stenosis | Procedure: Early surgery | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 145 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | early aortic valve replacement |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis |
Actual Study Start Date : | July 2010 |
Actual Primary Completion Date : | April 30, 2019 |
Actual Study Completion Date : | April 30, 2019 |

Arm | Intervention/treatment |
---|---|
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.
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Active Comparator: Early Surgery
Early surgery is performed within 2 months of randomization.
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Procedure: Early surgery
Early surgery is performed within 2 months of randomization.
Other Name: Early aortic valve replacement surgery |
- 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.
- 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.

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01161732
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 138-736 | |
Seoul National University Hospital | |
Seoul, Korea, Republic of | |
Yonsei University Medical Center | |
Seoul, Korea, Republic of |
Principal Investigator: | Duk-Hyun Kang, M.D. | Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Duk-Hyun Kang, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01161732 |
Other Study ID Numbers: |
2010-0065 |
First Posted: | July 14, 2010 Key Record Dates |
Last Update Posted: | May 3, 2019 |
Last Verified: | May 2019 |
aortic stenosis surgery, survival |
Aortic Valve Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Heart Valve Diseases |
Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |