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Optimising Pacemaker Therapy Using Multi-point Pacing (the OPT-MPP Study)

NCT03220659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-11-05

No results posted yet for this study

Summary

Recently, the introduction of quadripolar left ventricular leads (one with four pacing poles) has allowed the opportunity to pace the lateral (back) of the heart from several points at once using a single lead (multi-point pacing - MPP). Although it seems logical that electrical beginning at several points on the left ventricular wall should improve coordination of the heart, there is no consistent response in terms of improved remodeling (cardiac structure and function) or composite scores of patient-related status. The technology has a further disadvantage that it leads to accelerated battery drain, with on average one year less longevity over the lifetime of the device.

Aims are:

1. to explore the effect of MPP on the force-frequency relationship,
2. to examine the effects of MPP on exercise capacity measured by treadmill walk time and whether these are related to the FFR response to MPP in individual patients,
3. establish whether the acute contractile response is maintained to 6 months after the implant procedure and
4. determine whether the acute contractile response to MPP is associated with subsequent beneficial remodeling over a further six months.

Conditions

  • Heart Failure, Systolic

Interventions

DEVICE

Multi-point pacing

Pacing from more than one pole from the left ventricular lead

DEVICE

Standard settings

Normal bipolar LV pacing

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University of Leeds

    lead OTHER

Principal Investigators

  • Klaus Witte, MD · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-10-01
Completion
2020-11-01

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220659 on ClinicalTrials.gov