Long-term Prognosis and Valve Durability of Transcatheter Aortic Valve Replacement for Aortic Valve Disease: a Real-world, Prospective, Single-center, Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis and Insufficiency
- Sponsor
- Xijing Hospital
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Valve-related long-term clinical efficacy
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.
Investigators
LingTao
Professor in Cardiology, Director of the department of Cardiology
Xijing Hospital
Eligibility Criteria
Inclusion Criteria
- •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
- •Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
- •Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form
Exclusion Criteria
- •Patients who cannot provide informed consent
- •Patients who are participating in other clinical trials
Outcomes
Primary Outcomes
Valve-related long-term clinical efficacy
Time Frame: 5 years
* Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration * Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies) * Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
All-casuse mortality
Time Frame: 5 years
All-casuse mortality including cardiac death and non-cardiac death
Secondary Outcomes
- Rate of technical success(at exit from procedure room)
- Combined early safety and clinical efficacy outcomes(30 days)
- Rate of device success(discharge or 30 days)
- Combined clinical efficacy outcomes(5 years and 10 years)
- Valve-related long-term clinical efficacy(10 years)