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Trial record 8 of 233 for:    aortic valve replacement

The Asian Pacific TAVR Multicenter Registry (AP TAVR)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Queen Elizabeth Hospital, Hong Kong
Sponsor:
Collaborators:
Asan Medical Center
Cardiovascular Clinical Research
Information provided by (Responsible Party):
Michael Kang-Yin Lee, MD, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT02195102
First received: July 11, 2014
Last updated: November 17, 2014
Last verified: November 2014
  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
Device: Transcatheter aortic valve Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY

Resource links provided by NLM:


Further study details as provided by Queen Elizabeth Hospital, Hong Kong:

Primary Outcome Measures:
  • Death from any cause [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Death from any cause [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death from any cause [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death from any cause [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death from any cause [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death from any cause [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death from any cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death from cardiac cause [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Death from cardiac cause [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Death from cardiac cause [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death from cardiac cause [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death from cardiac cause [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death from cardiac cause [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death from cardiac cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Repeat hospitalization [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Repeat hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Repeat hospitalization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Repeat hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Repeat hospitalization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Repeat hospitalization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Repeat hospitalization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Acute kidney injury [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Vascular complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Vascular complication [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Vascular complication [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Vascular complication [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Vascular complication [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Vascular complication [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Vascular complication [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Bleeding events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Device success [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  • Device success [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  • Device success [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  • Device success [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  • Device success [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  • Device success [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  • Device success [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)


Estimated Enrollment: 2000
Study Start Date: December 2014
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
transcatheter aortic valve Replacement
Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
Device: Transcatheter aortic valve Replacement

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who had undergone transcatheter aortic valve replacement on the basis of inclusion criteria were prospectively&retrospectively included in the registry

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02195102

Contacts
Contact: Elly Jeong-youn Bae, Research Nurse cvcrc10@amc.seoul.kr

Locations
China
Queen Elizabeth Hospital Not yet recruiting
HongKong, China
Contact: Michael Kang-Yin Lee, MD       kylee1991@hotmail.com   
Principal Investigator: Michael Kang-Yin Lee, MD         
Nanjing 1st Hospital Not yet recruiting
Nanjing, China
Contact: Jun-Jie Zhang, MD       jameszll@163.com   
Principal Investigator: Jun-Jie Zhang, MD         
Japan
Shonan Kamakura General Hospital Not yet recruiting
Kamakura, Japan
Contact: Shigeru Saito, MD       saito@shonankamakura.or.jp   
Principal Investigator: Shigeru Saito, MD         
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jeong-youn Bae, Research nurse       cvcrc10@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD, PhD         
Malaysia
Institut Jantung Negara Not yet recruiting
Kuala Lumpur, Malaysia
Contact: Rosli Mohd Ali, MD       rosli@ijn.com.my   
Principal Investigator: Rosli Mohd Ali, MD         
Philippines
St. Luke's Medical Center Not yet recruiting
Bonifacio, Philippines
Contact: Enrique Fabio Posas, MD       febposas@gmail.com   
Principal Investigator: Enrique Fabio Posas, MD         
Singapore
National Heart Centre of Singapore Not yet recruiting
Singapore, Singapore
Contact: Paul Chiam, MD       paul.chiam.t.l@nhcs.com.sg   
Principal Investigator: Paul Chiam, MD         
National University Heart Centre Not yet recruiting
Singapore, Singapore
Contact: Edgar L.W. Tay, MD       Edgar_Tay@nuhs.edu.sg   
Principal Investigator: Edgar L.W. Tay, MD         
Taiwan
National Taiwan University Not yet recruiting
Taipei, Taiwan
Contact: Paul Kao, MD       hsienli_kao@yahoo.com   
Principal Investigator: Paul Kao, MD         
Thailand
King Chulalongkorn Memorial Hospital Not yet recruiting
Bangkok, Thailand
Contact: Wacin Buddhari, MD       wacin_buddhari@yahoo.com   
Principal Investigator: Wacin Buddhari, MD         
Sponsors and Collaborators
Michael Kang-Yin Lee, MD
Asan Medical Center
Cardiovascular Clinical Research
Investigators
Principal Investigator: Seung-jung Park, MD, PhD Asan Medical Center, Republic of Korea
Principal Investigator: Edgar L.W. Tay, MD National University Heart Center (National University Health System), Singapore
Principal Investigator: Machael Kang-Yin Lee, MD Queen Elizabeth Hospital, HongKong
  More Information

No publications provided

Responsible Party: Michael Kang-Yin Lee, MD, MD, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT02195102     History of Changes
Other Study ID Numbers: AMCCV 2013-12
Study First Received: July 11, 2014
Last Updated: November 17, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Queen Elizabeth Hospital, Hong Kong:
transcatheter aortic valve Replacement

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

ClinicalTrials.gov processed this record on November 25, 2014