Plain English Summary
Background and study aims
Aortic stenosis is a condition where the aortic valve of the heart becomes narrowed and stiff due to a build-up of calcium. In patients with aortic stenosis and a high or extreme risk for open surgery, transcatheter aortic valve implantation (TAVI) is the first line treatment. TAVI is a way of replacing the valve with a new valve (prosthesis) which is inserted through a small incision in the groin or through the chest wall, thereby improving how the heart works without the need for open heart surgery. There are several different types of TAVI prosthesis with different characteristics. The Lotus valve is a new and promising valve which enables the doctors to reposition or even remove the valve if they are unhappy with the position or the size of the valve. This offers a unique safety aspect of the device. A seal outside the valve also minimizes leak after implantation. The main drawback of the valve is that in previous studies, it has been associated with a 30 % risk of needing a pacemaker after implantation. The aim of this study is to assess the valve with regards to a new implantation technique aimed at reducing the risk of pacemaker after implantation.
Who can participate?
Patients aged over 18 who are eligible for TAVI and implantation with a Lotus Valve
What does the study involve?
Routinely collected data is used to assess the safety and effectiveness of the 100 first successful Lotus Valve implantations after 30 days and 12 months. Device success, mortality (death rate), pacemaker implantation rate, major complications, stroke and leak are all assessed.
What are the possible benefits and risks of participating?
All parts of this study are routine care for the patient and the data is routinely collected. This study doesn't require any extra examinations or undertakings for the patients. There are no particular risks or benefits associated with this study as it is part of follow-up of routine care.
Where is the study run from?
Skane University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
September 2013 to December 2016
Who is funding the study?
Skane University Hospital Cardiology Fund (Sweden)
Who is the main contact?
Dr Matthias Götberg
Dr Matthias Götberg
Department of Cardiology
Skane University Hospital
Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement
The rationale of this study was to evaluate the short- and long-term safety and efficacy of the new device with focus on a new implantation technique to reduce the need for a permanent pacemaker (PPM) post procedure.
Lund University ethics committee, 01/05/2009, ref: LU2009/87
Single-centre observational study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Patients with severe symptomatic aortic stenosis with high or extreme surgical risk eligible for TAVI
The 30-day and 12-month safety and efficacy of the 100 first successful Lotus Valve implantations will be evaluated in a prospective non-randomized registry.
Primary outcome measures
Device success according to VARC 2 criteria (periprocedural)
Secondary outcome measures
1. Mortality at 30 days and 12 months
2. Pacemaker implantation rate at discharge, 30 days and 12 months
3. Major vascular complications at discharge
4. Stroke at 30 days
5. Paravalvular leak at discharge and 12 months
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. >18 years old
2. Eligible for TAVI and eligible for implantation with a Lotus Valve as assessed by the interdisciplinary Heart Team
Target number of participants
Participant exclusion criteria
1. <18 years old
2. Other co-morbidity with expected life span <12 months
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Skane University Hospital
Skane University Hospital Cardiology Fund
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal. Since this is a registry study, no additional documents will be available.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository, but due to local regulation, it will not be publically available unless upon specific request of limited datasets.
Intention to publish date
Participant level data
Stored in repository
Results - basic reporting