AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function
Recruiting · NCT07428967 · Interventional (participants receive a specific treatment) · Lead sponsor: St. Josefs-Hospital Wiesbaden GmbH
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes. The primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.
Who can take part
Inclusion criteria
- History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy
- Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)
- AV node ablation scheduled independently of possible study participation
- Age ≥ 18 years
- Consent capacity
Exclusion criteria
- Impaired LVEF (\< 50%)
- Pre-implanted pacemaker
- Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)
- High grade (III°) left cardiac valvular disease
- Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI
- Body-mass-index \> 40 kg/m2
- Pregnancy
- Inability to give written informed consent
- Life expectancy \< 12 months
Where it is running
2 locations listed.
- Evangelisches Krankenhaus Hagen-Haspe - Hagen, Germany
- St. Josefs-Hospital Wiesbaden GmbH - Wiesbaden, Germany