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Pacing in Heart Failure With Preserved LVEF

NCT03215849 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-07-18

No results posted yet for this study

Summary

A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes.

The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board \[CVUHB\]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography.

All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order:

Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP

Conditions

Interventions

DEVICE

CRT-pacemaker device set to Routine Medical Therapy

Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy

DEVICE

CRT-pacemaker device set to Routine Medical Therapy + LVP

Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP

DEVICE

CRT-pacemaker device set to Routine Medical Therapy + BiVP

Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP

Sponsors & Collaborators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Cardiff Metropolitan University

    collaborator OTHER

  • Cardiff and Vale University Health Board

    lead OTHER_GOV

Principal Investigators

  • Zaheer Yousef · Cardiff and Vale University Health Board

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-20
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03215849 on ClinicalTrials.gov