Long-term Prognosis and Valve Durability of TAVR
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
2. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form
Disqualifiers
1. Patients who cannot provide informed consent
2. Patients who are participating in other clinical trials
Trial population
Consecutive patients with severe aortic stenosis or valve regurgitation undergo transcatheter aortic valve replacement (TAVR) following evaluation by a cardiac team.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transcatheter aortic valve replacement
Procedure/SurgeryA total of 1000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled. Clinical follow-up will be conducted in the periprocedural and after TAVR at 1 month, 5 years, and 10 years
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
All-casuse mortality
All-casuse mortality including cardiac death and non-cardiac death
Time frame
5 years2
Valve-related long-term clinical efficacy
* 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)
Time frame
5 yearsSecondary outcomes
1
Combined early safety and clinical efficacy outcomes
Composed by all-cause mortality, all strokes, life-threatening or fatal bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, conduction block and arrhythmia, surgery or intervention related to the device, any hospitalization, myocardial infarction, any other adverse events
Time frame
30 days2
Rate of technical success
* Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Time frame
at exit from procedure room3
Rate of device success
* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient\<20mmHg, and less than moderate aortic regurgitation)
Time frame
discharge or 30 days4
Combined clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality (cardiac/non-cardiac), all strokes, any hospitalization
Time frame
5 years and 10 yearsSponsors and contacts
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Source ClinicalTrials.gov