AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function (AVA CONDUCT)

AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Atrial Arrhythmia
• Intervention / Treatment: Procedure: RV pacing; Procedure: LBBA pacing

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hagen, Germany
    • Not yet recruiting
    • Evangelisches Krankenhaus Hagen-Haspe
    • Contact: Harilaos Bogossian, MD
  • Wiesbaden, Germany
    • Recruiting
    • St. Josefs-Hospital Wiesbaden GmbH
    • Contact: Joachim Ehrlich, MD; Phone Number: +496111771200; Email: jehrlich@joho.de
    • Principal Investigator: Joachim Ehrlich, MD
    • Principal Investigator: Andreas Boehmer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right ventricular pacing	Procedure: RV pacing; RV apical pacemaker implantation prior to AV node ablation
Active Comparator: Left bundle branch area pacing	Procedure: LBBA pacing; LBBA pacemaker implantation prior to AV node ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients developing pacemaker-induced cardiomyopathy	Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of < 50%	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular function	Left ventricular ejection fraction (%)	36 months
Left Ventricular Global Longitudinal Strain	Global longitudinal strain of the left ventricle (%)	36 months
Right ventricular function	Tricuspid Annular Plane Systolic Excursion (mm)	36 months
Right ventricular function	Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)	36 months
Right ventricular function	Right ventricular strain (%)	36 months
NT-proBNP serum concentration (ng/L)	NT-proBNP serum concentration (ng/L)	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.	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	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)	36 months

Collaborators and Investigators

• Sponsor: St. Josefs-Hospital Wiesbaden GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: AVA CONDUCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No