SWISS TAVI Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital Inselspital, Berne
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01368250
First received: June 6, 2011
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Aortic Stenosis
Procedure: Transcatheter Aortic Valve Implantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SWISS TAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: thirty days ] [ Designated as safety issue: Yes ]
  • Valve Academic Research Consortium (VARC) efficacy endpoint [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • New York Heart Association Functional Class [ Time Frame: one year ] [ Designated as safety issue: No ]

Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Elderly patients with symptomatic severe aortic stenosis, deemed at high risk for conventional aortic valve replacement
Procedure: Transcatheter Aortic Valve Implantation
Minimal Invasive Implantation of a biological prosthesis in Aortic Position

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 prospectively the safety and efficacy in a consecutively enrolled patient cohort undergoing TAVI using either the Edwards SAPIEN or Medtronic CoreValve device at Swiss cardiovascular centers. Currently, 12 centers are performing more than 200 TAVI interventions in total per year in Switzerland. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368250

Contacts
Contact: Peter Wenaweser, MD 0041 31 632 21 11 peter.wenaweser@insel.ch
Contact: Lorenz Räber, MD 0041 31 632 21 11 lorenz.raeber@insel.ch

Locations
Switzerland
Department of Cardiology Recruiting
Bern, Switzerland, 3010
Contact: Peter Wenaweser, MD    0041 31 632 21 11    peter.wenaweser@insel.ch   
Contact: Lorenz Raeber, MD    0041 31 632 21 11    lorenz.raeber@insel.ch   
Principal Investigator: Peter Wenaweser, MD         
Sub-Investigator: Stefan Stortecky, MD         
Department of Cardiothoracic Surgery Recruiting
Bern, Switzerland, 3010
Contact: Christoph Huber, MD    0041 31 632 21 11    christoph.huber@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Chair: Peter Wenaweser, MD Bern University Hospital
  More Information

No publications provided

Responsible Party: Peter Wenaweser, MD, SWISS TAVI working group
ClinicalTrials.gov Identifier: NCT01368250     History of Changes
Other Study ID Numbers: 056/11
Study First Received: June 6, 2011
Last Updated: January 7, 2013
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Keywords provided by University Hospital Inselspital, Berne:
Aortic
Stenosis
Valve
VARC
Transcatheter
Minimal-invasive

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014