SwissTAVI Registry

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Aortic Valve Disease Mixed

Treatments: Procedure: Transcatheter Aortic Valve Implantation

Study type: Observational

Funder types: Other

Identifiers

NCT01368250

056/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

20,000 participants in 3 patient groups

1

Description:

Patients with native aortic stenosis undergoing TAVI

Treatment:

Procedure: Transcatheter Aortic Valve Implantation

2

Description:

Patients with native aortic regurgitation undergoing TAVI

3

Description:

Patients with degenerative surgical bioprosthesis undergoing TAV-in-SAV