Atrial Arrhythmia, Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
PROCEDURERV pacing
RV apical pacemaker implantation prior to AV node ablation
PROCEDURELBBA pacing
LBBA pacemaker implantation prior to AV node ablation
Sponsors
St. Josefs-Hospital Wiesbaden GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy 2. Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method) 3. AV node ablation scheduled independently of possible study participation 4. Age ≥ 18 years 5. Consent capacity
Exclusion criteria
1. Impaired LVEF (\< 50%) 2. Pre-implanted pacemaker 3. Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details) 4. High grade (III°) left cardiac valvular disease 5. Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI 6. Body-mass-index \> 40 kg/m2 7. Pregnancy 8. Inability to give written informed consent 9. Life expectancy \< 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients developing pacemaker-induced cardiomyopathy | 36 months | Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of \< 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular function | 36 months | Left ventricular ejection fraction (%) |
| Left Ventricular Global Longitudinal Strain | 36 months | Global longitudinal strain of the left ventricle (%) |
| Right ventricular function | 36 months | Tricuspid Annular Plane Systolic Excursion (mm) |
| NT-proBNP serum concentration (ng/L) | 36 months | NT-proBNP serum concentration (ng/L) |
| Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score | 36 months | Ranging from 0 to 100 with higher scores represent a better outcome. |
| 6-minute walk distance (meters) | 36 months | — |
| All-cause mortality | 36 months | — |
| Number of patients with a rehospitalization due to heart failure/cardiac decompensation | 36 months | — |
| Number of patients with a rehospitalization due to pacemaker malfunction | 36 months | — |
| Number of patients with a rehospitalization due to atrial arrhythmia | 36 months | — |
| Number of patients experiencing a stroke or transient ischemic attack | 36 months | — |
| Procedure-related complications | 36 months | Number of patients with one of the following events: death, stroke and TIA; clinically relevant bleeding (Bleeding Academic Research Consortium ≥2) including hematoma at the pacemaker pocket prolonging hospital stay; thrombosis of subclavian/axillary/cubital vein; pneumothorax, pericardial effusion and tamponade; myocardial or septal perforation; coronary vessel injury, including fistula formation; pacemaker lead dislocation or perforation; infection, including pacemaker pocket infection, lead infection, and pacemaker-associated endocarditis; treatment-requiring groin complications such as aneurysm, AV fistula, or dissection (prolonging hospital stay) |
Countries
Germany
Outcome results
None listed