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Compares treatment options for Pacemaker DDD
Official title Conduction System Pacing With Left Bundle Branch Pacing as Compared to Standard Right Ventricular Pacing
ClinicalTrials.gov ID: NCT05015660
What this study is testing
- What it's testing
- High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF). High percentage ventricular pacing and wider paced QRS in the setting of normal baseline LV ejection fractions have consistently been shown to be independent risk factors for pacing-induced cardiomyopathy.
- This is a blinded study.
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
- Patients with an ejection fraction of \>35%
- Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is \>90%...
- Third degree AV block
- Symptomatic or asymptomatic second-degree AV block
You likely can't join if
- Indication for an implantable cardioverter defibrillator
- Presence of a mechanical tricuspid valve
- Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
- Lack of capacity to consent
- Other serious medical condition with life expectancy of \<2 years
- Pregnancy
See the full eligibility criteria
- Age ≥ 18 years
- Patients with an ejection fraction of \>35%
- Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is \>90% including:
- Third degree AV block
- Symptomatic or asymptomatic second-degree AV block
- First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms)
- Echocardiogram within the last 3 months, with ability to have DICOM images
- Indication for an implantable cardioverter defibrillator
- Presence of a mechanical tricuspid valve
- Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
- Lack of capacity to consent
- Other serious medical condition with life expectancy of \<2 years
- Pregnancy
- Patients in whom the conduction system abnormality is expected to be transient or recover over time
- Patients with permanent atrial fibrillation
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
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 Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
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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.