NCT03215849

Pacing in Heart Failure With Preserved LVEF

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cardiff and Vale University Health Board · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-20
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2017-07-12
• Last updated: 2024-07-18

Locations

1 site across 1 country: United Kingdom