- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02195102
The Asian Pacific TAVR Multicenter Registry (AP TAVR)
November 17, 2014 updated by: Michael Kang-Yin Lee, MD
Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elly Jeong-youn Bae, Research Nurse
- Email: cvcrc10@amc.seoul.kr
Study Locations
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HongKong, China
- Queen Elizabeth Hospital
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Contact:
- Michael Kang-Yin Lee, MD
- Email: kylee1991@hotmail.com
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Principal Investigator:
- Michael Kang-Yin Lee, MD
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Nanjing, China
- Nanjing 1st Hospital
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Contact:
- Jun-Jie Zhang, MD
- Email: jameszll@163.com
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Principal Investigator:
- Jun-Jie Zhang, MD
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Kamakura, Japan
- Shonan Kamakura General Hospital
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Contact:
- Shigeru Saito, MD
- Email: saito@shonankamakura.or.jp
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Principal Investigator:
- Shigeru Saito, MD
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Seoul, Korea, Republic of
- Asan Medical Center
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Principal Investigator:
- Seung-jung Park, MD, PhD
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Contact:
- Jeong-youn Bae, Research nurse
- Email: cvcrc10@amc.seoul.kr
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Kuala Lumpur, Malaysia
- Institut Jantung Negara
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Contact:
- Rosli Mohd Ali, MD
- Email: rosli@ijn.com.my
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Principal Investigator:
- Rosli Mohd Ali, MD
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Bonifacio, Philippines
- St. Luke's Medical Center
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Contact:
- Enrique Fabio Posas, MD
- Email: febposas@gmail.com
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Principal Investigator:
- Enrique Fabio Posas, MD
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Singapore, Singapore
- National Heart Centre of Singapore
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Contact:
- Paul Chiam, MD
- Email: paul.chiam.t.l@nhcs.com.sg
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Principal Investigator:
- Paul Chiam, MD
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Singapore, Singapore
- National University Heart Centre
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Contact:
- Edgar L.W. Tay, MD
- Email: Edgar_Tay@nuhs.edu.sg
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Principal Investigator:
- Edgar L.W. Tay, MD
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Taipei, Taiwan
- National Taiwan University
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Contact:
- Paul Kao, MD
- Email: hsienli_kao@yahoo.com
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Principal Investigator:
- Paul Kao, MD
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Bangkok, Thailand
- King Chulalongkorn Memorial Hospital
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Contact:
- Wacin Buddhari, MD
- Email: wacin_buddhari@yahoo.com
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Principal Investigator:
- Wacin Buddhari, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
transcatheter aortic valve Replacement
Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death from any cause
Time Frame: 4 years
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4 years
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Death from any cause
Time Frame: 5 years
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5 years
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Death from any cause
Time Frame: 1 month
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1 month
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Death from any cause
Time Frame: 6 months
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6 months
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Death from any cause
Time Frame: 1 year
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1 year
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Death from any cause
Time Frame: 2 years
|
2 years
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Death from any cause
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial infarction
Time Frame: 6 months
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6 months
|
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Myocardial infarction
Time Frame: 3 years
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3 years
|
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Myocardial infarction
Time Frame: 1 year
|
1 year
|
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Stroke
Time Frame: 5 years
|
5 years
|
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Myocardial infarction
Time Frame: 5 years
|
5 years
|
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Stroke
Time Frame: 4 years
|
4 years
|
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Stroke
Time Frame: 1 year
|
1 year
|
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Death from cardiac cause
Time Frame: 1 month
|
1 month
|
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Death from cardiac cause
Time Frame: 6 months
|
6 months
|
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Death from cardiac cause
Time Frame: 1 year
|
1 year
|
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Death from cardiac cause
Time Frame: 2 years
|
2 years
|
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Death from cardiac cause
Time Frame: 3 years
|
3 years
|
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Death from cardiac cause
Time Frame: 4 years
|
4 years
|
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Death from cardiac cause
Time Frame: 5 years
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5 years
|
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Stroke
Time Frame: 1 month
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1 month
|
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Stroke
Time Frame: 6 months
|
6 months
|
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Stroke
Time Frame: 2 years
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2 years
|
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Stroke
Time Frame: 3 years
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3 years
|
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Myocardial infarction
Time Frame: 1 month
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1 month
|
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Myocardial infarction
Time Frame: 2 years
|
2 years
|
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Myocardial infarction
Time Frame: 4 years
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4 years
|
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Repeat hospitalization
Time Frame: 1 month
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1 month
|
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Repeat hospitalization
Time Frame: 6 months
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6 months
|
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Repeat hospitalization
Time Frame: 1 year
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1 year
|
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Repeat hospitalization
Time Frame: 2 years
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2 years
|
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Repeat hospitalization
Time Frame: 3 years
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3 years
|
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Repeat hospitalization
Time Frame: 4 years
|
4 years
|
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Repeat hospitalization
Time Frame: 5 years
|
5 years
|
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Acute kidney injury
Time Frame: 1 month
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1 month
|
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Acute kidney injury
Time Frame: 6 months
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6 months
|
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Acute kidney injury
Time Frame: 1 year
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1 year
|
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Acute kidney injury
Time Frame: 2 years
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2 years
|
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Acute kidney injury
Time Frame: 3 years
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3 years
|
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Acute kidney injury
Time Frame: 4 years
|
4 years
|
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Acute kidney injury
Time Frame: 5 years
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5 years
|
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Vascular complication
Time Frame: 1 month
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1 month
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Vascular complication
Time Frame: 6 months
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6 months
|
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Vascular complication
Time Frame: 1 year
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1 year
|
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Vascular complication
Time Frame: 2 years
|
2 years
|
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Vascular complication
Time Frame: 3 years
|
3 years
|
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Vascular complication
Time Frame: 4 years
|
4 years
|
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Vascular complication
Time Frame: 5 years
|
5 years
|
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Bleeding events
Time Frame: 1 month
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1 month
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Bleeding events
Time Frame: 6 months
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6 months
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Bleeding events
Time Frame: 1 year
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1 year
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Bleeding events
Time Frame: 2 years
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2 years
|
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Bleeding events
Time Frame: 3 years
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3 years
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Bleeding events
Time Frame: 4 years
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4 years
|
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Bleeding events
Time Frame: 5 years
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5 years
|
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Device success
Time Frame: 1 month
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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)
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1 month
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Device success
Time Frame: 6 months
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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)
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6 months
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Device success
Time Frame: 1 year
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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)
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1 year
|
Device success
Time Frame: 2 years
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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)
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2 years
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Device success
Time Frame: 3 years
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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)
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3 years
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Device success
Time Frame: 4 years
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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)
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4 years
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Device success
Time Frame: 5 years
|
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)
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
July 11, 2014
First Submitted That Met QC Criteria
July 17, 2014
First Posted (Estimate)
July 21, 2014
Study Record Updates
Last Update Posted (Estimate)
November 18, 2014
Last Update Submitted That Met QC Criteria
November 17, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMCCV 2013-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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