Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278844
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-07
Brief Title:
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCPAND
Brief Summary:
This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity as measured by peak oxygen uptake VO2peak in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy CRT The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed
Detailed Description:
Heart failure HF is a serious condition that affects a lot of people and places a significant burden on the healthcare system Some HF patients also have issues with the natural electrical system of their heart causing uneven heart contractions and worsening heart function A treatment known as CRT has been helping such patients but it does not work for everyone A new technique called conduction system pacing CSP has emerged that might offer a more natural way of maintaining heart contractions
This study aims to determine if CSP can enhance the ability of HF patients to exercise by looking at their maximum oxygen consumption a measure of exercise capacity It will also explore why some HF patients struggle with exercise more than others Eligible patients will be randomly assigned to either the new CSP treatment or a standard pacing method right ventricular apical pacing Patients will be checked regularly over a follow-up period of 24 weeks
The main goal is to see if patients can exercise better with CSP after 24 weeks The study will also look at other heart measures and safety concerns related to the devices This study might show that CSP can help improve exercise capacity and heart function in certain HF patients The results could guide health care professionals in offering better tailored treatments for their patients
This study aims to determine if CSP can enhance the ability of HF patients to exercise by looking at their maximum oxygen consumption a measure of exercise capacity It will also explore why some HF patients struggle with exercise more than others Eligible patients will be randomly assigned to either the new CSP treatment or a standard pacing method right ventricular apical pacing Patients will be checked regularly over a follow-up period of 24 weeks
The main goal is to see if patients can exercise better with CSP after 24 weeks The study will also look at other heart measures and safety concerns related to the devices This study might show that CSP can help improve exercise capacity and heart function in certain HF patients The results could guide health care professionals in offering better tailored treatments for their patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None