Condition category
Circulatory System
Date applied
13/02/2017
Date assigned
20/02/2017
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Heart failure patients may benefit from Cardiac Resynchronisation Therapy (CRT), which involves having a special pacemaker implanted to help the heart pump in a more coordinated and efficient way. These pacemakers involve attaching a lead to the heart muscle in within the main heart chambers which delivers current to help the heart beat effectively (pacing leads). Current pacing leads stimulate the main chamber of the heart from one location. Only two thirds of people respond to CRT and this may be due to the need to stimulate the heart from more than one position. Previous attempts at using two pacing leads in the main chamber of the heart have proved technically difficult. Due to new technologies it is now possible to stimulate the heart from more than one site using one lead - MultiPoint™ Pacing (MPP). This lead can also function as a conventional pacing lead if the MPP mode is switched off. The aim of this study is to use this specialised lead in the main chamber of the heart and study the outcomes of patients with the MPP on and MPP off.

Who can participate?
Adults who are scheduled to have a CRT device implanted.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have their pacemaker set using the conventional method of pacing the left side of the heart from one location. Those in the second group have their pacemaker set to stimulate the left side from two locations. Participants in both groups are followed up for two years in order to find out how many episodes of irregular heart rate problems participants experience after they have had their pacemakers placed.

What are the possible benefits and risks of participating?
Participants may not benefit from taking part in this study. It is not known as to whether stimulating the main chamber of the heart from two locations will improve the effectiveness of pacemaker treatment. Although early work suggests that this will be beneficial, these benefits have not been proven in large studies yet, and this is one of the reasons that this research is being carried out. The information from this study may therefore help with the treatment of other patients in the future. There are no notable risks involved with participating.

Where is the study run from?
1. St Thomas Hospital (UK)
2. Basildon Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2016 to October 2020

Who is funding the study?
St Jude Medical UK Ltd (UK)

Who is the main contact?
Mrs Humra Chadwick
humra.chadwick1@gstt.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Humra Chadwick

ORCID ID

Contact details

Division of Imaging Sciences
4th Floor
North Wing
St Thomas Hospital
London
SE1 7EH
United Kingdom
+44 20 7188 7188 ext. 56217
humra.chadwick1@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32782

Study information

Scientific title

Does MultiPoint™ pacing (MPP) result in a greater rate of reverse remodelling in participants receiving cardiac resynchronisation therapy (CRT) when compared to conventional CRT and to assess if the rate of ventricular arrhythmias is affected with MPP?

Acronym

MPP VARR

Study hypothesis

MultiPoint™ Pacing (MPP) will increase the proportion of responders to Cardiac Resynchronisation Therapy (CRT) and this will also result in a reduction in the frequency of abnormal heart rhythms.

Ethics approval

01/09/2016, ref: 16/EM/0344

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Cardiovascular disease, Primary sub-specialty: Heart Failure; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease

Intervention

Participants undergoing CRT- D implant will either be randomised to have the pacemaker set at the conventional method of pacing the left side of the heart from one location (MPP off) or will have the pacemaker set to stimulate the left side from two locations (MPP on).

Participants randomised into the study will have a 6 month follow up for the primary end-point and a further 2 year follow up to evaluate the secondary endpoints. The total duration of the investigation will be 2 years.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Rate of left ventricular reverse remodelling is measured using LV volume reduction at 6 months.

Secondary outcome measures

Changes in the incidence of treated ventricular arrhythmias is measured by the number of incidents reported over the duration of the 2 years participant is in the study.

Overall trial start date

26/10/2016

Overall trial end date

26/10/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Scheduled to undergo an implant of a CRT-D system with approved standard indication by ESC/EHRA guidelines
2. Ability to provide informed consent for study participation and be willing to comply with the enrolment and follow up evaluations
3. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 344; UK Sample Size: 344

Participant exclusion criteria

1. Recent myocardial infarction within 40 days prior to enrolment
2. Cardiac surgery or coronary revascularisation procedure within 3 months prior to enrolment or be scheduled for such procedures in the following 7 months
3. Intravenous inotropic support within the last 30 days
4. Under 18 years of age
5. Be pregnant or plan to become pregnant over the next 7 months

Recruitment start date

26/10/2016

Recruitment end date

26/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Basildon Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust

Sponsor details

16th Floor Guy’s Tower
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 20 7188 9811
Jennifer.Boston@gstt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

St Jude Medical UK Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

26/10/2021

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.