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New treatment option for Heart Failure
Official title Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
ClinicalTrials.gov ID: NCT06620705
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Aarhus N, Denmark
- Leiden, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Aarhus N, Denmark; Leiden, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.