NCT06620705 Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
| NCT ID | NCT06620705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | srdpiers |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2024-09-10 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
Eligibility Criteria
INCLUSION CRITERIA In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy. * Expected percentage of ventricular pacing \> 40% * ≥ 3 months of heart failure medication optimization Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included EXCLUSION CRITERIA A potential subject who meets any of the following criteria will be excluded from participation in this study: * Age \< 18 years * Pregnancy or active pregnancy wish * Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus * Recent valve intervention/surgery or acute myocardial infarction (\< 6 months) * NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant
Contact & Investigator
Sebastiaan Piers, MD, PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center, Leiden, the Netherlands
Frequently Asked Questions
Who can join the NCT06620705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06620705 currently recruiting?
Yes, NCT06620705 is actively recruiting participants. Contact the research team at s.r.d.piers@lumc.nl for enrollment information.
Where is the NCT06620705 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Leiden, Netherlands.
Who is sponsoring the NCT06620705 clinical trial?
NCT06620705 is sponsored by srdpiers. The principal investigator is Sebastiaan Piers, MD, PhD at Leiden University Medical Center, Leiden, the Netherlands. The trial plans to enroll 34 participants.
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