Condition category
Circulatory System
Date applied
06/11/2017
Date assigned
08/11/2017
Last edited
07/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
matthias.gotberg@med.lu.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Matthias Götberg

ORCID ID

Contact details

Department of Cardiology
EA15
Skane University Hospital
Getingevagen 4
Lund
22185
Sweden
+46 (0)171000
matthias.gotberg@med.lu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Lotus 1.1

Study information

Scientific title

Single-center evaluation of a next generation fully repositionable and retrievable transcatheter aortic valve replacement

Acronym

Study hypothesis

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

Lund University ethics committee, 01/05/2009, ref: LU2009/87

Study design

Single-centre observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

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

19/09/2013

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. <18 years old
2. Other co-morbidity with expected life span <12 months

Recruitment start date

19/09/2013

Recruitment end date

19/09/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Skane University Hospital
Lund
22185
Sweden

Sponsor information

Organisation

Skane University Hospital

Sponsor details

Department of Cardiology
Getingevagen 4
Lund
22185
Sweden

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Skane University Hospital Cardiology Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/12/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes