Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

SWISS TAVI Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01368250
Recruitment Status : Recruiting
First Posted : June 7, 2011
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date June 6, 2011
First Posted Date June 7, 2011
Last Update Posted Date July 24, 2019
Study Start Date February 2011
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2019)
Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: one year ]
death, myocardial infarction, stroke, aortic valvular re-intervention
Original Primary Outcome Measures
 (submitted: June 6, 2011)
Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: one year ]
Change History Complete list of historical versions of study NCT01368250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 22, 2019)
  • Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: thirty days ]
    death, myocardial infarction, stroke, aortic valvular re-intervention
  • Valve Academic Research Consortium (VARC) efficacy endpoint [ Time Frame: one year ]
    death, myocardial infarction, stroke, aortic valvular re-intervention
  • New York Heart Association Functional Class [ Time Frame: one year ]
    Classifying the extent of heart failure: Limitations/Symptoms during physical activities.
Original Secondary Outcome Measures
 (submitted: June 6, 2011)
  • Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: thirty days ]
  • Valve Academic Research Consortium (VARC) efficacy endpoint [ Time Frame: one year ]
  • New York Heart Association Functional Class [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SWISS TAVI Registry
Official Title SWISS TAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
Brief Summary Aortic valve stenosis represents the clinically most important valvular heart disease in the elderly patient population. For several decades, surgical aortic valve replacement has been considered the standard in the treatment of symptomatic patients with aortic stenosis. Patients deemed at excessive-risk for conventional aortic valve replacement were treated conservatively with a very poor prognosis. In the search for less invasive treatment options for this elderly patient population, transcatheter aortic valve implantation (TAVI) was introduced in 2002 and since then has been established as an alternative, less invasive treatment option for non-operable or high-risk patients for conventional surgery. 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

Background

Aortic valve stenosis represents the clinically most important valvular heart disease in the elderly patient population. After onset of symptoms including chest pain, congestive heart failure or syncope, prognosis decreases substantially and the average survival amounts to only 2 to 3 years without surgical intervention. For several decades, surgical aortic valve replacement has been considered the standard in the treatment of symptomatic patients, resulting in effective symptom relief and improvement of prognosis. Patients deemed at excessive-risk for conventional aortic valve replacement were treated conservatively with a very poor prognosis. In the search for less invasive treatment options, transcatheter aortic valve implantation (TAVI) was introduced in 2002. TAVI represents an alternative, less invasive treatment option for non-operable or high-risk patients for conventional surgery. TAVI has shown to be technically feasible with a procedural success rate of > 90% in several registries. Most recently, a randomized, controlled clinical trial in patients deemed inoperable, and non-inferiority when compared to surgical aortic valve replacement among patients considered to be at high risk demonstrated the superiority of TAVI as compared to medical treatment alone in patients deemed inoperable for conventional aortic valve replacement.

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.

Objective

The purpose of this multi-center 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.

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 five years.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with severe aortic valve stenosis or degenerated aortic bioprosthesis scheduled to undergo transcatheter aortic valve implantation (TAVI) using the commercially available devices with the CE approval are eligible for enrollment in the registry. The TAVI procedure can be performed using all available access routes (transfemoral, transapical, trans-subclavian, trans-aortic).
Condition Aortic Stenosis
Intervention Procedure: Transcatheter Aortic Valve Implantation
Minimal Invasive Implantation of a biological prosthesis in Aortic Position
Study Groups/Cohorts 1
Elderly patients with symptomatic severe aortic stenosis, deemed at high risk for conventional aortic valve replacement
Intervention: Procedure: Transcatheter Aortic Valve Implantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 15, 2017)
3000
Original Estimated Enrollment
 (submitted: June 6, 2011)
1000
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Symptomatic severe aortic stenosis
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Peter Wenaweser, MD 0041 31 632 21 11 peter.wenaweser@insel.ch
Contact: Stefan Stortecky, MD 0041 31 632 83 52 stefan.stortecky@insel.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01368250
Other Study ID Numbers 056/11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators Not Provided
Investigators
Study Chair: Peter Wenaweser, MD Bern University Hospital
PRS Account University Hospital Inselspital, Berne
Verification Date July 2019