AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Number of patients developing pacemaker-induced cardiomyopathy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Inability to give written informed consent
- •Life expectancy < 12 months
Arms & Interventions
Right ventricular pacing
Intervention: RV pacing (Procedure)
Left bundle branch area pacing
Intervention: LBBA pacing (Procedure)
Outcomes
Primary Outcomes
Number of patients developing pacemaker-induced cardiomyopathy
Time Frame: 36 months
Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of \< 50%
Secondary Outcomes
- Left ventricular function(36 months)
- Left Ventricular Global Longitudinal Strain(36 months)
- Right ventricular function(36 months)
- NT-proBNP serum concentration (ng/L)(36 months)
- Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score(36 months)
- 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)