NCT06620705Recruiting
Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction
Pacing Away from Heart Failure: Left Bundle Branch Area Pacing or Biventricular Pacing in Patients with Atrial Fibrillation and Left Ventricular Dysfunction
Source: ClinicalTrials.gov · Last updated 1 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 10 Sept 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- srdpiers
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06620705
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 10 Sept 2024 to the primary completion date, Sept 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Recent valve intervention/surgery or acute myocardial infarction (\< 6 months)
- NYHA functional class IV heart failure, left ventricular assist device or cardiac transplant
Age
- Age \< 18 years
Other
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or active pregnancy wish
- Not eligible for implantation of an RV lead, LBBAP lead, or LV lead in the coronary sinus
Who the study is looking for
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adults ≥18 years with permanent AF and LVEF \< 50% who either require ventricular pacing because of bradycardia including patients undergoing AV junction ablation, or have an indication for cardiac resynchronization therapy.
- Expected percentage of ventricular pacing \> 40%
- ≥ 3 months of heart failure medication optimization
- Of note, patients who already have a device, but require an upgrade to a CRT device, can also be included
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Not yet recruiting |
| Leiden University Medical Center Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.