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ENROLLING BY INVITATION
NCT03215849
NA

Pacing in Heart Failure With Preserved LVEF

Sponsor: Cardiff and Vale University Health Board

View on ClinicalTrials.gov

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

Official title: The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-07-20

Completion Date

2025-03-31

Last Updated

2024-07-18

Healthy Volunteers

No

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

Locations (1)

University Hospital Wales

Cardiff, United Kingdom