BridgeMD
New treatment option for Atrial Fibrillation (AF)
Official title Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation
ClinicalTrials.gov ID: NCT06699342
What this study is testing
What is Pharmacologic therapy optimized for Atrial Fibrillation management?
Pharmacologic therapy optimized for Atrial Fibrillation management is an investigational medicine, being studied as a potential treatment for atrial fibrillation (af).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.
- 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 65 and older
You may be able to join if
- Inclusion: Patients who meet all of the following 1)-6).
- Permanent atrial fibrillation
- Age ≥ 65 years
- Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
- New York Heart Association (NYHA) functional class II- IV
You likely can't join if
- 1)-11).
- Asymptomatic atrial fibrillation
- Life expectancy to \< 12 months.
- Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
- Mechanical tricuspid valve replacement
- Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis...
See the full eligibility criteria
- Inclusion: Patients who meet all of the following 1)-6).
- Permanent atrial fibrillation
- Age ≥ 65 years
- Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation
- New York Heart Association (NYHA) functional class II- IV
- LVEF \> 40% (within the past 3 months)
- Patients with at least one of the following:
- HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 12 months
- Elevated NT-proBNP (\>900 pg/ml) in the 30 days prior to enrollment Exclusion: Patients who meet at least one of the following
- 1)-11).
- Asymptomatic atrial fibrillation
- Life expectancy to \< 12 months.
- Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)
- Mechanical tricuspid valve replacement
- Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis)
- Obstructive hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
- Acute coronary syndrome or coronary revascularization (CABG or PCI) \<3 months
- Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation
- Pacemaker/ICD/CRT treatment ongoing, or current pacemaker indication
- Simultaneous participation in a different assigned by chance clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Jongno-gu, South Korea
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, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Jongno-gu, South Korea. 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.