Condition category
Circulatory System
Date applied
23/03/2015
Date assigned
30/04/2015
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
With every heartbeat the aortic valve opens to allow blood to leave the main pumping chamber of the heart to supply the tissues and organs of the human body. Over time and as a natural consequence of ageing, the aortic valve leaflets (there are usually three) can become stiff, open less well and the valve opening (orifice) is narrowed as a result. This is called aortic valve stenosis, which is the most common form of heart valve disease in the developed world. The aortic valve orifice can become so narrowed that an individual can become symptomatic and suffer chest pain, shortness of breath, a reduction in exercise capacity and loss of consciousness. Before these symptoms can take hold it is standard medical practice for the patient to be considered for aortic valve replacement via open heart surgery. Indeed severe symptomatic aortic stenosis is often fatal if left untreated, whilst timely relief of the mechanical obstruction can restore normal life expectancy. Surgical aortic valve replacement is an operation associated with a small but significant risk of death and other complications. In those patients who may be frail and/or suffer other medical problems, that risk may be heightened to such an extent that the benefits of the operation may be outweighed by the risks attached. In the past, patients declined for an aortic valve operation would have no other alternative but to continue their tablet therapy. In 2002, the first transcatheter aortic valve implantation (TAVI) procedure was performed. This was a new method of replacing the aortic valve without having to perform open heart surgery. With TAVI a replacement aortic valve, fashioned from cow or pig heart tissue mounted on an expandable metallic frame, is placed across the native aortic valve via a main artery in the groin, chest, or neck or directly through the bottom tip of the heart via a small incision in the lower left ribcage. The TAVI procedure has now become established as a therapeutic strategy for the management of severe aortic stenosis in those patients who do not qualify for a surgical aortic valve replacement. The close proximity of the aortic valve apparatus to the native electrical conduction system of the heart lends to an increased propensity for the development of excessively slow heart rhythms. Following traditional surgical aortic valve replacement, for instance, a permanent pacemaker is required in 2-8% of patients postoperatively to prevent the heart rate from falling too low. Following a TAVI procedure the occurrence of electrical conduction abnormalities can be even higher. For the purposes of the 3B Study, we are focusing on a specific heart rhythm abnormality called Left Bundle Branch Block (LBBB), which has been noted to occur following a small percentage of TAVI procedures. The exact percentage of patients likely to suffer LBBB following a TAVI procedure is unknown as is its relation to harmful complications such as an impairment in the overall pumping function of the heart, and more seriously, whether the emergence of LBBB can increase the likelihood of death following a TAVI procedure. We will study, in a retrospective fashion, all the TAVI procedures that have taken place since the inception of the service at each participating institution up until the 31st of December 2013. This study will represent the largest database of TAVI procedures in which the occurrence of LBBB post procedure has been analysed in the medical literature to date. The information gleaned from the study will help us to determine the prognostic significance of LBBB post TAVI procedure. If LBBB is found to be detrimental to the survival of patients post TAVI, further studies can then be designed to determine what therapeutic interventions can be put in place to improve outcome in this specific patient subgroup.

Who can participate?
Patients undergoing the TAVI procedure at one of the participating centres within the period from the start of the TAVI programme at their trial participating centre until the 31st December 2013.

What does the study involve?
For all the participants in the study we will determine: (1) how many developed LBBB following TAVI; (2) whether the development of LBBB led to an increased risk of death within a year following the TAVI operation; (3) whether the development of LBBB led to an increased risk of death from a cardiovascular cause 1 year after the TAVI operation; and (4) whether the development of LBBB led to a reduction in the pumping function of the heart at 30 days and at 1 year after the TAVI operation.

What are the possible benefits and risks of participating?
There are no benefits of risks associated with taking part in this study

Where is the study run from?
A total of 18 NHS hospitals across the UK

When is the study starting and how long is it expected to run for?
February 2015 to December 2015

Who is funding the study?
King's College London (UK)

Who is the main contact?
1. Dr Satpal Arri (public)
satpal.arri@gmail.com
2. Dr Aung Myat (public)
aung.myat@nhs.net (scientific)
3. Professor Simon Redwood
simon.redwood@gstt.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Satpal Arri

ORCID ID

Contact details

The Rayne Institute BHF Centre of Research Excellence
4th Floor
Lambeth Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 207 188 1008
satpal.arri@gmail.com

Type

Public

Additional contact

Dr Aung Myat

ORCID ID

Contact details

The Rayne Institute BHF Centre of Research Excellence
4th Floor
Lambeth Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 207 188 1008
aung.myat@nhs.net

Type

Scientific

Additional contact

Professor Simon Redwood

ORCID ID

Contact details

Cardiothoracic Directorate
6th Floor
East Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 207 188 1083
simon.redwood@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.0

Study information

Scientific title

New left bundle branch block following transcatheter aortic valve implantation and its effect on survival - a United Kingdom experience.

Acronym

The 3B Investigators Study

Study hypothesis

New onset left bundle branch block after successful transcatheter aortic valve implantation increases 1-year all cause mortality.

Ethics approval

National Research Ethics Service (NRES) Committee North West - Lancaster of the National Health Service of the United Kingdom, 18/11/2014, ref: 14/NW/1456

Study design

A retrospective United Kingdom multi-centre observational registry.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Transcatheter aortic valve implantation for the percutaneous treatment of calcific degenerative aortic valve stenosis.

Intervention

Left bundle branch block (LBBB) is the most common conduction abnormality following transcatheter aortic valve implantation (TAVI). Whilst LBBB in the post surgical and heart failure population is known to carry a poor prognosis, the prognostic significance of new LBBB following TAVI is less well delineated. TAVI-induced LBBB has been shown to negatively affect cardiac function and increase re-hospitalisation, although its direct impact on mortality remains a subject of increasing relevance and continuing debate. This UK-wide retrospective observational registry aims to gain further insight into the prognostic significance of newly diagnosed LBBB in all patients undergoing successful TAVI device implantation (irrespective of device manufacturer) from inception of the TAVI programme at a participating institution to the 31st of December 2013.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

All-cause mortality at 1 year following transcatheter aortic valve implantation.

Secondary outcome measures

1. Cardiovascular mortality at 1 year following transcatheter aortic valve implantation.
2. Need for permanent pacemaker implantation following transcatheter aortic valve implantation.
3. Left ventricular ejection fraction at 30 days and at 1 year following transcatheter aortic valve implantation.

Overall trial start date

18/02/2015

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All patients undergoing successful transcatheter aortic valve implantation (TAVI), irrespective of device manufacturer, from the inception of the TAVI programme at the participating institution until the 31st December 2013.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Previous/pre-existing permanent pacemaker in situ.
2. Unsuccessful transcatheter aortic valve implantation procedure.

Recruitment start date

18/02/2015

Recruitment end date

01/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
St Thomas' Hospital Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Tremona Road Southampton
Hampshire
SO16 6YD
United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
177 Preston Road
Brighton
BN1 6AG
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Trust
Level 3, John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

The London Chest Hospital, Barts Health NHS Trust
Bonner Road
London
E2 9JX
United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom

Trial participating centre

Liverpool Heart and Chest Hospital NHS Foundation Trust
Thomas Drive Liverpool
Merseyside
L14 3PE
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Medical Centre
Birmingham
B15 2TH

Trial participating centre

Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Trial participating centre

Hammersmith Hospital, Imperial College Healthcare NHS Trust
Du Cane Road
London
W12 0HS
United Kingdom

Trial participating centre

University Hospital of North Staffordshire NHS Trust
Newcastle Road Stoke-on-Trent
Staffordshire
ST4 6QG
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Nottingham
United Kingdom

Trial participating centre

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle-upon-Tyne
United Kingdom

Trial participating centre

Royal Victoria Hospital, Belfast Health and Social Care Trust
Belfast
United Kingdom

Trial participating centre

Plymouth Hospitals NHS Trust
Plymouth
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
Leeds
United Kingdom

Trial participating centre

The Royal Brompton Hospital, Royal Brompton and Harefield NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

K0.58 King's Building Strand Campus
London
WC2 R2LS
United Kingdom
+44 207 848 6960
barbara.dahill@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

King's College London

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish a methods/protocol paper very shortly which will detail the study design as already described on the ISRCTN registry application. Thereafter the main results paper will be submitted to a major international general medical journal.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes