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SwissTAVI Registry

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ClinicalTrials.gov Identifier: NCT01368250
Recruitment Status : Recruiting
First Posted : June 7, 2011
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment
Aortic Valve Disease Mixed Procedure: Transcatheter Aortic Valve Implantation

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.

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
Study Start Date : February 2011
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368250


Contacts
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Contact: Stefan Stortecky, MD 0041 31 632 83 52 stefan.stortecky@insel.ch
Contact: Stephan Windecker, MD 0041 31 632 83 52 stephan.windecker@insel.ch

Locations
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Switzerland
Department of Cardiology Recruiting
Bern, Switzerland, 3010
Contact: Stefan Stortecky, MD    0041 31 632 21 11    stefan.stortecky@insel.ch   
Principal Investigator: Stefan Stortecky, MD         
Department of Cardiology Recruiting
Bern, Switzerland, 3010
Contact: Stephan Windecker, MD    0041 31 632 21 11    stephan.windecker@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Stefan Stortecky, MD Bern University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01368250    
Other Study ID Numbers: 056/11
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: June 2021
Keywords provided by University Hospital Inselspital, Berne:
Aortic valve
Heart valve
VARC
Transcatheter
Minimal-invasive
TAVI
TAVR
Additional relevant MeSH terms:
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Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases