SWISS TAVI Registry
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|ClinicalTrials.gov Identifier: NCT01368250|
Recruitment Status : Recruiting
First Posted : June 7, 2011
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment|
|Aortic Stenosis||Procedure: Transcatheter Aortic Valve Implantation|
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.
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.
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|
|Estimated Enrollment :||3000 participants|
|Official Title:||SWISS TAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
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
- Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: one year ]death, myocardial infarction, stroke, aortic valvular re-intervention
- 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.
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
|Contact: Peter Wenaweser, MD||0041 31 632 21 email@example.com|
|Contact: Stefan Stortecky, MD||0041 31 632 83 firstname.lastname@example.org|
|Department of Cardiology||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Peter Wenaweser, MD 0041 31 632 21 11 email@example.com|
|Principal Investigator: Peter Wenaweser, MD|
|Department of Cardiothoracic Surgery||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Christoph Huber, MD 0041 31 632 21 11 firstname.lastname@example.org|
|Study Chair:||Peter Wenaweser, MD||Bern University Hospital|