SwissTAVI Registry

December 14, 2022 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with aortic valve disease or degenerated aortic bioprosthesis scheduled to undergo transcatheter aortic valve implantation (TAVI) using commercially available devices with CE approval are eligible for enrollment in the registry. The TAVI procedure can be performed using all available access routes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients with native aortic stenosis undergoing TAVI
Procedure: Transcatheter Aortic Valve Implantation
Minimal Invasive Implantation of a biological prosthesis in Aortic Position
2
Patients with native aortic regurgitation undergoing TAVI
3
Patients with degenerative surgical bioprosthesis undergoing TAV-in-SAV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time Frame: 1 year

Composed by:

  • death
  • stroke
  • aortic valve re-intervention
  • structural valve deterioration
  • myocardial Infarction
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time Frame: 30days

Composed by:

  • death
  • stroke
  • aortic valve re-intervention
  • myocardial Infarction
  • kidney injury
  • access related complications
  • pacemaker requirements
30days
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time Frame: 5 years

Composed by:

  • death
  • stroke
  • aortic valve re-intervention
  • structural valve deterioration
5 years
combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
Time Frame: 10 years , 15 years

Composed by:

  • death
  • stroke
  • aortic valve re-intervention
  • structural valve deterioration
10 years , 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Study Chair: Stefan Stortecky, MD, Bern University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 056/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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