AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function

St. Josefs-Hospital Wiesbaden GmbH86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atrial Fibrillation Atrial Arrhythmia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Evangelisches Krankenhaus Hagen-Haspe

Hagen, Germany

NOT_YET_RECRUITING

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, Germany

RECRUITING

Outcomes

Primary Outcomes

Number of patients developing pacemaker-induced cardiomyopathy

Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of \< 50%

Time frame: 36 months

Secondary Outcomes

Left ventricular function

Left ventricular ejection fraction (%)

Time frame: 36 months

Left Ventricular Global Longitudinal Strain

Global longitudinal strain of the left ventricle (%)

Time frame: 36 months

Right ventricular function

Tricuspid Annular Plane Systolic Excursion (mm)

Time frame: 36 months

Right ventricular function

Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)

Time frame: 36 months

Right ventricular function

Right ventricular strain (%)

Time frame: 36 months

NT-proBNP serum concentration (ng/L)

Time frame: 36 months

Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score

Ranging from 0 to 100 with higher scores represent a better outcome.

Time frame: 36 months

6-minute walk distance (meters)

Time frame: 36 months

All-cause mortality

Time frame: 36 months

Number of patients with a rehospitalization due to heart failure/cardiac decompensation

Time frame: 36 months

Number of patients with a rehospitalization due to pacemaker malfunction

Time frame: 36 months

Number of patients with a rehospitalization due to atrial arrhythmia

Time frame: 36 months

Number of patients experiencing a stroke or transient ischemic attack

Time frame: 36 months

Procedure-related complications

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)

Time frame: 36 months