Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
ConditionAortic Valve Regurgitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXijing Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
2. Patients who understand the purpose of this 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 treated with TAVR for aortic stenosis
3. Patients who are participating in other clinical trials
Trial population
Patients with pure severe native aortic valve regurgitation underwent TAVR
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transcatheter aortic valve replacement
Procedure/SurgeryA 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
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Combined clinical efficacy outcomes
Combined clinical efficacy outcomes as composed by all-cause mortality, all strokes, any hospitalization
Time frame
1 yearSecondary 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, all strokes, any hospitalization
Time frame
2 years, 3 years, 4 yearsSponsors and contacts
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Source ClinicalTrials.gov