SwissTAVI Registry

Aortic Valve Disease Mixed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01368250
• Other study ID #: 056/11
• Status: Recruiting
• Start date: February 2011
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Stefan Stortecky, MD
• Phone: 0041 31 632 83 52
• Email: stefan.stortecky[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Disease Mixed

Intervention

Procedure:
• Transcatheter Aortic Valve Implantation
Minimal Invasive Implantation of a biological prosthesis in Aortic Position

Locations

Country	Name	City	State
Switzerland	Department of Cardiology	Bern
Switzerland	Department of Cardiology	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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