Status:
ACTIVE_NOT_RECRUITING
Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy
Lead Sponsor:
AZ Sint-Jan AV
Conditions:
Heart Failure with Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy. Our primary hypothesis is that left bundle branch area pacing (L...
Detailed Description
Recently some retrospective or uncontrolled studies were published that compared cardiac resynchronization therapy (CRT) using left bundle branch area pacing (LBBAP) and biventricular pacing (BiV), al...
Eligibility Criteria
Inclusion
- Aged 18 or above
- Left Ventricular Ejection Fraction (LVEF) and NYHA meeting one off the previous indications documented with transthoracic echocardiography (TTE) no later than 3 months before randomization.
- New York Heart Association (NYHA) class II-IV
- Baseline left bundle branch block and QRS \>130ms or QRS \>150ms of any morphology or a wide paced QRS duration.
Exclusion
- Younger than 18 years old
- Pregnancy
- Any unstable medical condition, life expectancy \< 12 months
- Inability to provide consent or to undergo follow-up
- Narrow QRS duration (≤130ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm.
- Significant hypertrophic cardiomyopathy - any septum abnormality contra-indicating LBBAP implantation (according to physician's evaluation)
- Patients who are unable to perform a 6 minute walk test (6MWT) Note: patients should be able to perform a 6 minute walk test, but it is not a requirement to have the test performed before the procedure (e.g. due to inability of planning).
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2028
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05365568
Start Date
September 1 2022
End Date
September 30 2028
Last Update
September 23 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
UZA
Edegem, Antwerpen, Belgium, 2650
2
CHU Charleroi
Lodelinsart, Henegouwen, Belgium, 6042
3
Jessa Ziekenhuis Hasselt
Hasselt, Limburg, Belgium, 3500
4
CHR Citadelle Liège
Liège, Liège, Belgium, 4000