Aortic Valve Disease Mixed Clinical Trial
Official title:
RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | January 1, 2034 |
Est. primary completion date | November 1, 2033 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy 2. Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form Exclusion Criteria: 1. Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR 2. Patients who cannot tolerate the materials or medications associated with this study 3. Women who are pregnant or breastfeeding 4. Patients who participated in a clinical trial of another drug or medical device before enrollment |
Country | Name | City | State |
---|---|---|---|
China | Ling Tao | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3) | Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction | 1 year | |
Secondary | Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3) | Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, acute kidney injury, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, vascular and access-related complications, structural cardiac complications, any other adverse events | 30 days | |
Secondary | Rate of technical success | 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 devicea or to a major vascular or access-related, or cardiac structural complication |
at exit from procedure room | |
Secondary | Rate of device success | 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, peak velocity <3 m/s, Doppler velocity index >_0.25, and less than moderate aortic regurgitation) |
discharge or 30 days | |
Secondary | Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3) | Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, any other adverse events | 2 years, 3 years, 4 years | |
Secondary | Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3) | Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, structural valve deterioration, any other adverse events | 5 years and 10 years |
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