NCT05365568Active, not recruiting
Left Bundle Branch Area Pacing Using Conventional Stylet-driven Pacemaker Leads for Cardiac Resynchronization Therapy
Left Bundle Branch Area Pacing Using Conventional Stylet Driven Pacemaker Leads for Cardiac Resynchronization Therapy: a Randomized Study
Source: ClinicalTrials.gov · Last updated 23 Sept 2024
Brief summary (registry, in English)
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 (LBBAP) using conventional stylet driven pacemaker leads is an effective resynchronization method that yield to at least similar clinical benefits and outcomes when compare to biventricular pacing.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 170 (actual)
- First submitted
- 29 Apr 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- AZ Sint-Jan AV
- Diseases
- Heart failure
- NCT number
- NCT05365568
What you commit to
- Study type: Interventional
- Participants enrolled: 170
- From 1 Sept 2022 to the primary completion date, 30 Sept 2025
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any unstable medical condition, life expectancy \< 12 months
Age
- Younger than 18 years old
Other
- Pregnancy
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| UZA Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| CHU HELORA - Site Jolimont Coordinator of this site? Confirm its status | Haine-Saint-Paul | Belgium | Unknown status |
| Jessa Ziekenhuis Hasselt Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHR Citadelle Liège Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| CHU Charleroi Coordinator of this site? Confirm its status | Lodelinsart | Belgium | Unknown status |
| Clinique Saint-Pierre Ottignies Coordinator of this site? Confirm its status | Ottignies-Louvain-la-Neuve | Belgium | Unknown status |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| UCL - Saint Luc Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.