The effect of MultiPoint™ pacing on reverse remodelling and the incidence of ventricular arrhythmias – The MPP VARR Study
| ISRCTN | ISRCTN36496918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36496918 |
| Secondary identifying numbers | 32782 |
- Submission date
- 13/02/2017
- Registration date
- 20/02/2017
- Last edited
- 23/05/2020
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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?
Matthew Osmond
Matthew.osmond@gstt.nhs.uk
Contact information
Public
1st Floor Gassiot House
St Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Matthew.osmond@gstt.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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? |
| Study acronym | MPP VARR |
| Study objectives | 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(s) | 01/09/2016, ref: 16/EM/0344 |
| Health condition(s) or problem(s) studied | Abnormal heart rhythms |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 26/10/2016 |
| Completion date | 26/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 344; UK Sample Size: 344 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/10/2016 |
| Date of final enrolment | 26/10/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE1 7EH
United Kingdom
Basildon
SS16 5NL
United Kingdom
Sponsor information
Hospital/treatment centre
16th Floor Guy’s Tower
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 20 7188 9811 |
|---|---|
| Jennifer.Boston@gstt.nhs.uk | |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 26/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/05/2020: The public contact has been updated and the plain English summary has been updated accordingly. Due to current public health guidance, recruitment for this study has been paused.
28/03/2019: The condition has been changed from "Specialty: Cardiovascular disease, Primary sub-specialty: Heart Failure; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease" to "Abnormal heart rhythms" following a request from the NIHR.
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.
