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Compares treatment options for Atrial Fibrillation (AF)
Official title Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
ClinicalTrials.gov ID: NCT07250529
What this study is testing
- What it's testing
- This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate episodes (AHREs) in patients with preserved left ventricular ejection fraction (LVEF) who are expected to require frequent ventricular pacing. Atrial High-Rate Episodes (AHREs) are defined as episodes of atrial tachyarrhythmia that are automatically recorded by device diagnostics and detected by implanted cardiac devices.
- 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
- Age ≥ 18 years
- Scheduled implantation of a dual-chamber pacemaker for: Permanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)
- Documented preserved LVEF (≥50%)
- Sinus rhythm at baseline
- Ability to provide written informed consent
You likely can't join if
- History of paroxysmal, persistent, or permanent atrial fibrillation
- Previous atrial fibrillation ablation (catheter-based or surgical)
- LVEF \< 50%
- Sinus node disease
- Transient AV block requiring pacemaker implantation
- Significant structural or valvular heart disease
See the full eligibility criteria
- Age ≥ 18 years
- Scheduled implantation of a dual-chamber pacemaker for: Permanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)
- Documented preserved LVEF (≥50%)
- Sinus rhythm at baseline
- Ability to provide written informed consent
- History of paroxysmal, persistent, or permanent atrial fibrillation
- Previous atrial fibrillation ablation (catheter-based or surgical)
- LVEF \< 50%
- Sinus node disease
- Transient AV block requiring pacemaker implantation
- Significant structural or valvular heart disease
- Requirement for pacemaker system upgrade during the study period
- Requirement for antiarrhythmic therapy for causes other than atrial fibrillation
- Existing pacemaker or other cardiac device requiring modification for study participation
- Enrollment in another clinical trial that could interfere with study endpoints or pacing parameters
- Contraindication to LBBP or associated lead implantation procedure
- Life expectancy \< 12 months
- Any condition judged by the investigator to compromise participation or the integrity of study data
The study team makes the final eligibility decision.
Where it's taking place
- Pátrai, Greece
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 Pátrai, Greece. 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.