Aortic Valve Disease Mixed Clinical Trial
Official title:
SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
NCT number | NCT01368250 |
Other study ID # | 056/11 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 2011 |
Est. completion date | May 2025 |
The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to include patients in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to five years.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Native aortic valve stenosis - Native aortic valve regurgitation - Degenerated aortic bioprosthesis requiring treatment Exclusion Criteria - Patients refuses informed consent to participate in the registry - Contraindication for TAVI - High probability of non-adherence to the follow up - requirements |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Cardiology | Bern | |
Switzerland | Department of Cardiology | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by:
death stroke aortic valve re-intervention structural valve deterioration myocardial Infarction |
1 year | |
Secondary | combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by:
death stroke aortic valve re-intervention myocardial Infarction kidney injury access related complications pacemaker requirements |
30days | |
Secondary | combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by:
death stroke aortic valve re-intervention structural valve deterioration |
5 years | |
Secondary | combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) | Composed by:
death stroke aortic valve re-intervention structural valve deterioration |
10 years , 15 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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