Evaluation of a new type of heart valve - a single-center experience
| ISRCTN | ISRCTN14952278 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14952278 |
| Secondary identifying numbers | Lotus 1.1 |
- Submission date
- 06/11/2017
- Registration date
- 08/11/2017
- Last edited
- 18/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
matthias.gotberg@med.lu.se
Contact information
Scientific
Department of Cardiology, EA15
Skane University Hospital
Getingevagen 4
Lund
22185
Sweden
| Phone | +46 (0)171000 |
|---|---|
| matthias.gotberg@med.lu.se |
Study information
| Study design | Single-centre observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement |
| Study objectives | 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. |
| Ethics approval(s) | Lund University ethics committee, 01/05/2009, ref: LU2009/87 |
| Health condition(s) or problem(s) studied | Patients with severe symptomatic aortic stenosis with high or extreme surgical risk eligible for TAVI |
| Intervention | 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 19/09/2013 |
| Completion date | 01/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key 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 |
| Key exclusion criteria | 1. <18 years old 2. Other co-morbidity with expected life span <12 months |
| Date of first enrolment | 19/09/2013 |
| Date of final enrolment | 19/09/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
22185
Sweden
Sponsor information
University/education
Department of Cardiology
Getingevagen 4
Lund
22185
Sweden
"ROR" |
https://ror.org/02z31g829 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/02/2019 | 18/12/2019 | Yes | No |
Editorial Notes
18/12/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
