ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 469 for:    aortic valve replacement

ASAN Medical Center Aortic Valve Replacement Registry (ASAN-AVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03298178
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Suk Jung Choo, Asan Medical Center

Brief Summary:
This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: TAVR Procedure: SAVR

Detailed Description:
All TAVR and SAVR cases will be enrolled retrospectively and prospectively.

Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ASAN Medical Center Aortic Valve Replacement Registry
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
all aortic stenosis Procedure: TAVR
All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea
Other Name: transcatheter aortic valve replacement
Procedure: SAVR
All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea



Primary Outcome Measures :
  1. All cause death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 1,6 and 12 months and 5 years ]
  2. Cardiovascular mortality [ Time Frame: 1,6 and 12 months and 5 years ]
    Death due to proximate cardiac cause Death caused by noncoronary vascular condition All procedure-related/surgery-related death All valve-related death Sudden or unwitnessed death Death of unknown cause

  3. Myocardial infarction [ Time Frame: 1,6 and 12 months and 5 years ]
  4. Stroke [ Time Frame: 1,6 and 12 months and 5 years ]
    all stroke and TIA

  5. Bleeding [ Time Frame: 1,6 and 12 months and 5 years ]
  6. Operation site complication [ Time Frame: 1,6 and 12 months and 5 years ]
  7. Vascular access site and access-related complication [ Time Frame: 1,6 and 12 months and 5 years ]
  8. Acute kidney injury [ Time Frame: at a later date between 30 days or discharge ]
  9. Event rate of permanent pacemaker insertion [ Time Frame: 1,6 and 12 months and 5 years ]
  10. Other TAVR-related complication [ Time Frame: 1,6 and 12 months and 5 years ]
    Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment(TAV : Transcatheter Aortic Valve)

  11. Prosthetic valve dysfunction [ Time Frame: 1,6 and 12 months and 5 years ]
    Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation

  12. Event rate of composite endpoint [ Time Frame: 1,6 and 12 months and 5 years ]
    Device success Early safety within 30 days Clinical efficacy after 30 days defined as death, stroke, valve dysfunction or heart failure requiring hospitalization, severe dyspnea or valve dysfunction NYHA class III or IV

  13. Structural valve deterioration [ Time Frame: 1,6 and 12 months and 5 years ]
  14. Change of NYHA class [ Time Frame: 30 days and 1 year ]
    the New York Heart Association (NYHA) Functional Classification

  15. Change of valve area [ Time Frame: 30 days and 1 year ]
  16. Free from atrial fibrillation [ Time Frame: 1,6 and 12 months and 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All successful transcatheter aortic valve replacement or surgical aortic valve replacement
Criteria

Inclusion Criteria:

  • All successful transcatheter aortic valve replacement or surgical aortic valve replacement
  • Written consent

Exclusion Criteria

  • Infective endocarditis

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): NCT03298178


Contacts
Contact: Do-yoon Kang, MD 82230101745 kdy1218@gmail.com

Locations
Korea, Republic of
Asan Medical Hospital Recruiting
Seoul, Korea, Republic of
Contact: Suk-jung Choo, MD       sjchoo@amc.seoul.kr   
Principal Investigator: Suk-jung Choo, MD         
Sponsors and Collaborators
Suk Jung Choo
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-jung Park, MD Asan Medical Center

Responsible Party: Suk Jung Choo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03298178     History of Changes
Other Study ID Numbers: AMCCV 2017-09
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Suk Jung Choo, Asan Medical Center:
TAVR
TAVI
SAVR

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction