Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
1 other identifier
observational
500
1 country
1
Brief Summary
The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2018
CompletedFirst Submitted
Initial submission to the registry
April 18, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2034
April 24, 2024
April 1, 2024
15.9 years
April 18, 2024
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
1 year
Secondary Outcomes (6)
Combined early safety and clinical efficacy outcomes
30 days
Rate of technical success
at exit from procedure room
Rate of device success
discharge or 30 days
Combined clinical efficacy outcomes
2 years, 3 years, 4 years
Rate of all-cause mortality
5years and 10years
- +1 more secondary outcomes
Interventions
A total of 500 consecutive patients with NAVR undergoing TAVR will be enrolled at 3-5 centers. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years
Eligibility Criteria
Patients with pure severe native aortic valve regurgitation underwent TAVR
You may qualify if:
- \. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
- \. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
You may not qualify if:
- \. Patients who cannot provide informed consent
- \. Patients who are treated with TAVR for aortic stenosis
- \. Patients who are participating in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shannxi, 710032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ling Tao, M.D, Ph.D
Xijing Hospital
- STUDY CHAIR
Rutao Wang, M.D, Ph.D
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Cardiology, Director of the department of Cardiology
Study Record Dates
First Submitted
April 18, 2024
First Posted
April 24, 2024
Study Start
October 30, 2018
Primary Completion (Estimated)
October 1, 2034
Study Completion (Estimated)
October 1, 2034
Last Updated
April 24, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share