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
Primary Outcome
Major Adverse Cardiac and Cerebrovascular Events
Secondary Outcome
Major Adverse Cardiac and Cerebrovascular Events
Condition
Aortic Stenosis
Intervention
Transcatheter Aortic Valve Implantation
Study Arms / Comparison Groups
1
Description: Elderly patients with symptomatic severe aortic stenosis, deemed at high risk for conventional aortic valve replacement
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
3000
Start Date
February 2011
Completion Date
May 2025
Primary Completion Date
May 2025
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Peter Wenaweser, MD, 0041 31 632 21 11, [email protected]
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT01368250
Organization ID
056/11
Responsible Party
Sponsor
Study Sponsor
University Hospital Inselspital, Berne
Study Sponsor
Peter Wenaweser, MD, Study Chair, Bern University Hospital
Verification Date
July 2020