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Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction

RECRUITINGN/ASponsored by srdpiers
Actively Recruiting
PhaseN/A
Sponsorsrdpiers
Started2024-09-10
Est. completion2027-09
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Block, HeartHeart DiseaseHeart FailurePacing-Induced Cardiomyopathy

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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