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Compares treatment options for Atrioventricular Block
Official title Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
ClinicalTrials.gov ID: NCT07236489
What this study is testing
- What it's testing
- Transcatheter aortic valve implantation (TAVI) has rapidly expanded over the past decade as a treatment for severe aortic valve stenosis, with over 14,000 procedures performed in France in 2021. A common complication following TAVI is traumatic atrioventricular block requiring pacemaker implantation, occurring in about 10% of patients.
- 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
- Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
- Preserved left ventricular ejection fraction (LVEF ≥ 50%)
- Indications for pacemaker implantation according to guidelines, including :
- Third-degree atrioventricular (AV) block
- Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
You likely can't join if
- Left ventricular ejection fraction (LVEF) \< 50% before TAVI
- Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
- Previously implanted pacemaker
- Patients under legal guardianship, curatorship, or judicial protection
- Participation in another treatment therapeutic clinical trial
See the full eligibility criteria
- Patients who have undergone TAVI for severe aortic valve disease within the past 3 months
- Preserved left ventricular ejection fraction (LVEF ≥ 50%)
- Indications for pacemaker implantation according to guidelines, including :
- Third-degree atrioventricular (AV) block
- Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1
- Alternating left and right bundle branch block
- HV interval ≥ 70 ms during electrophysiological study
- Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI
- Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation
- Signed informed consent
- Patient affiliated with the national health insurance system
- Left ventricular ejection fraction (LVEF) \< 50% before TAVI
- Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis)
- Previously implanted pacemaker
- Patients under legal guardianship, curatorship, or judicial protection
- Participation in another treatment therapeutic clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Brest, Finistère, France
- Rennes, Ille-et-Vilaine, France
- Tours, Indre-et-Loire, France
- Nantes, Loire-Atlantique, France
- Clermont-Ferrand, Puy-de-Dôme, France
- Rouen, Seine-Maritime, France
- Poitiers, Vienne, France
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 Brest, Finistère, France; Rennes, Ille-et-Vilaine, France; Tours, Indre-et-Loire, France; Nantes, Loire-Atlantique, France; Clermont-Ferrand, Puy-de-Dôme, France; Rouen, Seine-Maritime, France and 1 more location(s). 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.