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

NCT03220659 | Completed

• 1 other identifier: 229391
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 1.to explore the effect of MPP on the force-frequency relationship,
2. 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. 3.establish whether the acute contractile response is maintained to 6 months after the implant procedure and
4. 4.determine whether the acute contractile response to MPP is associated with subsequent beneficial remodeling over a further six months.

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

• Force frequency curve (phase 1)

  Contractility curve over heart rate range

  Acute - cross-over phase at 6 weeks

Secondary Outcomes (4)

• Quality of life (MLWHF)

  From 6 months to 12 months following implant

• Quality of life (EQ5D-5L)

  From 6 months to 12 months following implant

• Treadmill walk time (phase 2)

  From 6 months to 12 months following implant - chronic parallel group phase

• Force frequency curve (phase 1)

  Acute - cross-over phase at 6 months

Other Outcomes (1)

• Battery longevity after 6 months of MPP versus usual pacing

  From 6 months to 12 months following implant

Study Arms (2)

Standard settings

PLACEBO COMPARATOR

Usual pacing programming

Device: Standard settings

Multi-point pacing

EXPERIMENTAL

MPP programming

Device: Multi-point pacing

Interventions

Multi-point pacing DEVICE

Pacing from more than one pole from the left ventricular lead

Also known as: MPP

Multi-point pacing

Standard settings DEVICE

Normal bipolar LV pacing

Also known as: CRT pacing

Standard settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic heart failure due to left ventricular systolic dysfunction (LVEF\<35%)
• Due to (or just undergone) undergo CRT implantation
• Able to perform a peak exercise test
• Willing and able to give informed consent

You may not qualify if:

• Atrial fibrillation
• Angina pectoris symptoms limiting exercise tolerance
• Unstable heart failure symptoms (medical therapy changes in last three months
• Poor imaging quality such that analysis is unreliable
• Calcium channel blockers (CCBs)

Sponsors & Collaborators

• University of Leeds: lead
• Medtronic: collaborator

Study Sites (1)

Leeds General Infirmary

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Klaus Witte, MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 18, 2017
• Study Start: November 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

GB (1)