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Aortic StenosisRECOVERYNCT01161732

Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

A study testing Early surgery in people with Aortic Stenosis, run by Asan Medical Center at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Aortic Stenosis
What is being tested?
Early surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
4 sitesSouth Korea
Study dates
Jul 2010to 30 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Exertional dyspnea
  • Angina
  • Syncope
  • Left ventricular ejection fraction < 50%
  • Significant aortic regurgitation
  • Significant mitral valve disease
Show all 10Show fewer
  • Pregnancy
  • Age < 20 years or > 80 years
  • Coexisting malignancies
  • Positive exercise test

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

  • Seoul National University Hospital

    Seoul

  • Yonsei University Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Randomized Comparison of Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

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.

Read the 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.

Conditions
Aortic Stenosis
Being tested
Early surgery
Keywords
aortic stenosis, surgery, survival
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early surgeryProcedure or surgery

    Also called Early aortic valve replacement surgery

    Early surgery is performed within 2 months of randomization.

Study groups in NCT01161732
Study groupRoleWhat they receive
Conventional treatmentNo interventionIn 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.
Early SurgeryActive comparatorEarly surgery is performed within 2 months of randomization.
Receives: Procedure: Early surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac mortality

    defined as death from complications of myocardial infarction, heart failure, shock, complications of cardiac surgery or intervention, other cardiovascular diseases including sudden cardiac death

    Measured: Entire follow-up ( a minimum of 10 years)

  2. Operative mortality

    Operative mortality is defined as death within 30 days of surgery.

    Measured: up to 30 days after surgery

Secondary outcomes (4)

  1. All-cause death

    Measured: Entire follow-up (a minimum of 10 years)

  2. Repeat aortic valve surgery

    Measured: Entire follow-up (a minimum of 10 years)

  3. Clinical thromboembolic events

    Diagnosis of thromboembolic events is based on clinical symptoms, signs and imaging studies.

    Measured: Entire follow-up (a minimum of 10 years)

  4. Hospitalization due to congestive heart failure

    A hospitalization due to congestive heart failure is defined as an unplanned, urgent admission for the management of congestive heart failure.

    Measured: Entire follow-up (a minimum of 10 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2010 (estimated)
  2. Study startJul 2010
  3. Primary completion30 May 2025
  4. Study completion30 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
early aortic valve replacement
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01161732
Sponsor's protocol ID
2010-0065
Acronym
RECOVERY
Status last verified
Jun 2025
First submitted
12 Jul 2010
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 20308614

  • Kang DH, Park SJ, Kim GY, Lee S, Sun BJ, Kim JB, Jung SH, Kim HK, Yun SC, Hong GR, Song JM, Chung CH. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis at 10 Years. N Engl J Med. 2026 Mar 26;394(12):1167-1174. doi: 10.1056/NEJMoa2511920.

    PubMed 41880613

  • Park SJ, Lee S, Lee SA, Kim DH, Kim HK, Hong GR, Song JM, Chung CH, Park SW, Kang DH. Impact of Early Surgery and Staging Classification on Survival in Asymptomatic Very Severe Aortic Stenosis. J Am Coll Cardiol. 2021 Feb 2;77(4):506-508. doi: 10.1016/j.jacc.2020.11.045. No abstract available.

    PubMed 33509403

  • Kang DH, Park SJ, Lee SA, Lee S, Kim DH, Kim HK, Yun SC, Hong GR, Song JM, Chung CH, Song JK, Lee JW, Park SW. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N Engl J Med. 2020 Jan 9;382(2):111-119. doi: 10.1056/NEJMoa1912846. Epub 2019 Nov 16.

    PubMed 31733181

Questions about this trial

What is this clinical trial studying?

A study testing Early surgery in people with Aortic Stenosis, run by Asan Medical Center at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac mortality (time frame: Entire follow-up ( a minimum of 10 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01161732, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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