SwissTAVI Registry

Recruiting

• Conditions: Aortic Valve Disease Mixed
• Interventions: Procedure: Transcatheter Aortic Valve Implantation

• Registration Number: NCT01368250
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Transcatheter Aortic Valve Implantation	Patients with native aortic stenosis undergoing TAVI

Primary Outcome Measures

Name	Time	Method
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)	1 year	Composed by: * death; * stroke; * aortic valve re-intervention; * structural valve deterioration; * myocardial Infarction

Secondary Outcome Measures

Name	Time	Method
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)	10 years , 15 years	Composed by: * death; * stroke; * aortic valve re-intervention; * structural valve deterioration
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)	30days	Composed by: * death; * stroke; * aortic valve re-intervention; * myocardial Infarction; * kidney injury; * access related complications; * pacemaker requirements

Trial Locations

Locations (1)

Department of Cardiology; 🇨🇭 Bern, Switzerland