Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

NCT01161732 | Completed DMC

• 1 other identifier: 2010-0065
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 4

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.

Conditions

Aortic Stenosis

Keywords

aortic stenosis; surgery, survival

Outcome Measures

Primary Outcomes (2)

• 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

  Entire follow-up ( a minimum of 10 years)

• Operative mortality

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

  up to 30 days after surgery

Secondary Outcomes (4)

• All-cause death

  Entire follow-up (a minimum of 10 years)

• Repeat aortic valve surgery

  Entire follow-up (a minimum of 10 years)

• Clinical thromboembolic events

  Entire follow-up (a minimum of 10 years)

• Hospitalization due to congestive heart failure

  Entire follow-up (a minimum of 10 years)

Study Arms (2)

Conventional treatment

NO INTERVENTION

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.

Early Surgery

ACTIVE COMPARATOR

Early surgery is performed within 2 months of randomization.

Procedure: Early surgery

Interventions

Early surgery PROCEDURE

Early surgery is performed within 2 months of randomization.

Also known as: Early aortic valve replacement surgery

Early Surgery

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Korean Institute of Medicine: collaborator

Study Sites (4)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University Medical Center

Seoul, South Korea

Location

Related Publications (3)

• 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.

  PMID: 20308614 BACKGROUND

• 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.

  PMID: 33509403 DERIVED

• 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.

  PMID: 31733181 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Duk-Hyun Kang, M.D.

  Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: early aortic valve replacement

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 14, 2010
• Study Start: July 1, 2010
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

KR (4)