BridgeMD
Compares treatment options for Heart Failure
Official title Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
ClinicalTrials.gov ID: NCT05769036
What this study is testing
- What it's testing
- Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization and decreased quality of life.
- 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 to 80
You may be able to join if
- The patient is willing and able to comply with the protocol and has provided written informed consent;
- Male or female patients aged 18 to 80 years;
- Patients with ischemic or non-ischemic cardiomyopathy;
- Symptomatic HF for at least 3 months prior to enrollment in the study;
- New York Heart Association (NYHA) functional class HF ≥ II;
You likely can't join if
- Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;
- Acute myocardial infarction within 3 months prior to enrollment;
- Acute coronary syndrome;
- Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);
- Patients listed for heart transplant;
- Patients with implanted cardiac assist device;
See the full eligibility criteria
- The patient is willing and able to comply with the protocol and has provided written informed consent;
- Male or female patients aged 18 to 80 years;
- Patients with ischemic or non-ischemic cardiomyopathy;
- Symptomatic HF for at least 3 months prior to enrollment in the study;
- New York Heart Association (NYHA) functional class HF ≥ II;
- Patients with HF in sinus rhythm (SR) with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with LBBB morphology;
- Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration 130-149 ms with LBBB morphology;
- Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with non-LBBB morphology;
- Patients with symptomatic persistent or permanent atrial fibrillation, HF with LVEF \< 40% (measured in the last 6 weeks prior to enrollment) and an uncontrolled heart rate who are candidates for atrioventricular...
- Patients with HF, LVEF \< 40% (measured in the last 6 weeks prior to enrollment) and indications for continuous ventricular pacing due to bradycardia;
- Patients who have received a conventional pacemaker or an implanted cardioverter-defibrillator and who subsequently develop symptomatic HF with LVEF \< 40% (measured in the last 6 weeks prior to enrollment) despite...
- Optimal HF medical therapy.
- Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;
- Acute myocardial infarction within 3 months prior to enrollment;
- Acute coronary syndrome;
- Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);
- Patients listed for heart transplant;
- Patients with implanted cardiac assist device;
- Acute myocarditis;
- Infiltrative myocardial disease;
- Hypertrophic cardiomyopathy;
- Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;
- Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;
- Mental or physical inability to participate in the study;
- Patients unable or unwilling to cooperate within the study protocol;
- Patients with rheumatic heart disease;
- Mechanic tricuspid valve patients;
- Patients with any serious medical condition that could interfere with this study;
- Enrollment in another investigational drug or device study;
- Patients not available for follow-up;
- Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml/min/1.73 m2);
- Life expectancy ≤ 12 months;
- Participation in another telemonitoring concept.
The study team makes the final eligibility decision.
Where it's taking place
- Tomsk, Russia
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tomsk, Russia. 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.