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Trial record 8 of 428 for:    aortic valve replacement

The Asian Transcatheter Aortic Valve Replacement Registry (Asian TAVR)

This study is currently recruiting participants.
Verified June 2017 by Seung-Jung Park, Asan Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02308150
First Posted: December 4, 2014
Last Update Posted: June 20, 2017
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.
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center
  Purpose
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population

Condition Intervention
Aortic Valve Stenosis Aortic Diseases Device: transcatheter aortic valve replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population

Resource links provided by NLM:


Further study details as provided by Seung-Jung Park, Asan Medical Center:

Primary Outcome Measures:
  • Death [ Time Frame: 1 month ]
  • Death [ Time Frame: 6 months ]
  • Death [ Time Frame: 1 year ]
  • Death [ Time Frame: 2 years ]
  • Death [ Time Frame: 3 years ]
  • Death [ Time Frame: 4 years ]
  • Death [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Death from cardiac cause [ Time Frame: 1 month ]
  • Death from cardiac cause [ Time Frame: 6 months ]
  • Death from cardiac cause [ Time Frame: 1 year ]
  • Death from cardiac cause [ Time Frame: 2 years ]
  • Death from cardiac cause [ Time Frame: 3 years ]
  • Death from cardiac cause [ Time Frame: 4 years ]
  • Death from cardiac cause [ Time Frame: 5 years ]
  • Stroke [ Time Frame: 1 month ]
  • Stroke [ Time Frame: 6 months ]
  • Stroke [ Time Frame: 1 year ]
  • Stroke [ Time Frame: 2 years ]
  • Stroke [ Time Frame: 3 years ]
  • Stroke [ Time Frame: 4 years ]
  • Stroke [ Time Frame: 5 years ]
  • Myocardial infarction [ Time Frame: 1 month ]
  • Myocardial infarction [ Time Frame: 6 months ]
  • Myocardial infarction [ Time Frame: 1 year ]
  • Myocardial infarction [ Time Frame: 2 years ]
  • Myocardial infarction [ Time Frame: 3 years ]
  • Myocardial infarction [ Time Frame: 4 years ]
  • Myocardial infarction [ Time Frame: 5 years ]
  • Repeat hospitalization [ Time Frame: 1 month ]
  • Repeat hospitalization [ Time Frame: 6 months ]
  • Repeat hospitalization [ Time Frame: 1 year ]
  • Repeat hospitalization [ Time Frame: 2 years ]
  • Repeat hospitalization [ Time Frame: 3 years ]
  • Repeat hospitalization [ Time Frame: 4 years ]
  • Repeat hospitalization [ Time Frame: 5 years ]
  • Acute kidney injury [ Time Frame: 1 month ]
  • Acute kidney injury [ Time Frame: 6 months ]
  • Acute kidney injury [ Time Frame: 1 year ]
  • Acute kidney injury [ Time Frame: 2 years ]
  • Acute kidney injury [ Time Frame: 3 years ]
  • Acute kidney injury [ Time Frame: 4 years ]
  • Acute kidney injury [ Time Frame: 5 years ]
  • Vascular complication [ Time Frame: 1 month ]
  • Vascular complication [ Time Frame: 6 months ]
  • Vascular complication [ Time Frame: 1 year ]
  • Vascular complication [ Time Frame: 2 years ]
  • Vascular complication [ Time Frame: 3 years ]
  • Vascular complication [ Time Frame: 4 years ]
  • Vascular complication [ Time Frame: 5 years ]
  • Bleeding events [ Time Frame: 1 month ]
  • Bleeding events [ Time Frame: 6 months ]
  • Bleeding events [ Time Frame: 1 year ]
  • Bleeding events [ Time Frame: 2 years ]
  • Bleeding events [ Time Frame: 3 years ]
  • Bleeding events [ Time Frame: 4 years ]
  • Bleeding events [ Time Frame: 5 years ]
  • Device success [ Time Frame: 1 month ]
  • Device success [ Time Frame: 6 months ]
  • Device success [ Time Frame: 1 year ]
  • Device success [ Time Frame: 2 years ]
  • Device success [ Time Frame: 3 years ]
  • Device success [ Time Frame: 4 years ]
  • Device success [ Time Frame: 5 years ]

Estimated Enrollment: 2000
Study Start Date: December 2014
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: transcatheter aortic valve replacement
    Other Name: TAVR
  Eligibility

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 patients who will undergo TAVR in Asian Pacific countries
Criteria

Inclusion Criteria:

  • Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site
  Contacts and Locations
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): NCT02308150


Contacts
Contact: Seung-Jung Park, MD sjpark@amc.seoul.kr

Locations
Australia
Royal Perth Hospital Not yet recruiting
Perth, Australia
Contact: Gerald Yong, MD       gstyong@gmail.com   
Principal Investigator: Gerald Yong, MD         
Japan
Shonan Kamakura General Hospital Not yet recruiting
Kamakura, Japan
Contact: Shigeru Saito, MD       saito@shonankamakura.or.jp   
Principal Investigator: Shigeru Saito, MD         
Kokura Memorial Hospital Not yet recruiting
Kitakyushu, Japan
Contact: Shinichi Shirai, MD       shirai@circulation.jp   
Principal Investigator: Shinichi Shrai, MD         
Keio University Not yet recruiting
Minato, Japan
Contact: Kentaro Hayashida, MD       k-hayashida@umin.ac.jp   
Principal Investigator: Kentaro Hayashida, MD         
Teikyo University School of medicine Not yet recruiting
Tokyo, Japan
Contact: Yusuke Watanabe, MD       yusuke0831@gmail.com   
Principal Investigator: Yusuke Watanabe, MD         
Saiseikai Yokohama-city Eastern Hospital Not yet recruiting
Yokohama, Japan
Contact: Motoharu Araki, MD       m_araki@tobu.saiseikai.or.jp   
Principal Investigator: Motoharu Araki, MD         
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Seung-jung Park, MD, PhD    82-2-3010-4812    sjpark@amc.seoul.kr   
Contact: Jeong-youn Bae    82-2-3010-7259    cvcrc10@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyo-soo Kim, MD       hyosoo@snu.ac.kr   
Principal Investigator: Hyo-soo Kim, MD         
Singapore
National University Heart Centre Recruiting
Singapore, Singapore
Contact: Edgar Tay, MD       edgar_tay@nuhs.edu.sg   
Principal Investigator: Edgar Tay, MD         
Taiwan
Cheng Hsin General Hospital Not yet recruiting
Taipei, Taiwan
Contact: Wei Hsian Yin, MD       yinwh88@gmail.com   
Principal Investigator: Wei Hsian Yin, MD         
National Taiwan University Not yet recruiting
Taipei, Taiwan
Contact: Paul Hsien Li Kao, MD       hsienli_kao@yahoo.com   
Principal Investigator: Paul Hsien Li Kao, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-jung Park, MD Asan Medical Center
Principal Investigator: Paul Hsien Li Kao, MD National Taiwan University, Taiwan
Principal Investigator: Shigeru Saito, MD Shonan Kamakura General Hospital, Japan
Principal Investigator: Gerald Yong, MD Royal Perth Hospital, Australia
Principal Investigator: Kentaro Hayashida, MD Keio University, JAPAN
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung-Jung Park, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02308150     History of Changes
Other Study ID Numbers: AMCCV2014-14
First Submitted: December 2, 2014
First Posted: December 4, 2014
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Keywords provided by Seung-Jung Park, Asan Medical Center:
transcatheter aortic valve replacement
asian pacific
asian

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