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SwissTAVI Registry

SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01368250
Enrollment
20000
Registered
2011-06-07
Start date
2011-02-28
Completion date
2025-05-31
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease Mixed

Keywords

Aortic valve, Heart valve, VARC, Transcatheter, Minimal-invasive, TAVI, TAVR

Brief summary

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.

Detailed description

The present registry aims to assess the safety and efficacy of TAVI with CE approved devices at Swiss cardiovascular centers. The Swiss Working group of Interventional Cardiology and Acute Coronary Syndrome decided to establish a nationwide registry in collaboration with the Swiss Society of Cardiac Surgery in order to assess the procedural and clinical outcome of TAVI patients. This prospective registry will help to identify candidates for TAVI, will report on peri-procedural outcome and on long-term efficacy of the devices. Last but not least it is a tool to increase quality of treatment of this high-risk patient population. Methods This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.

Interventions

PROCEDURETranscatheter Aortic Valve Implantation

Minimal Invasive Implantation of a biological prosthesis in Aortic Position

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)1 yearComposed by: * death * stroke * aortic valve re-intervention * structural valve deterioration * myocardial Infarction

Secondary

MeasureTime frameDescription
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)30daysComposed by: * death * stroke * aortic valve re-intervention * myocardial Infarction * kidney injury * access related complications * pacemaker requirements
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)5 yearsComposed by: * death * stroke * aortic valve re-intervention * structural valve deterioration

Countries

Switzerland

Contacts

Primary ContactStefan Stortecky, MD
stefan.stortecky@insel.ch0041 31 632 83 52
Backup ContactStephan Windecker, MD
stephan.windecker@insel.ch0041 31 632 83 52

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026