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NCT Number: NCT07428967

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Arrhythmia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelisches Krankenhaus Hagen-Haspe, Hagen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RV pacing

Procedure

RV apical pacemaker implantation prior to AV node ablation

LBBA pacing

Procedure

LBBA pacemaker implantation prior to AV node ablation

Primary outcomes

  1. 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

  1. Left ventricular function

    Time frame: 36 months

    Left ventricular ejection fraction (%)

  2. Left Ventricular Global Longitudinal Strain

    Time frame: 36 months

    Global longitudinal strain of the left ventricle (%)

  3. Right ventricular function

    Time frame: 36 months

    Tricuspid Annular Plane Systolic Excursion (mm)

  4. Right ventricular function

    Time frame: 36 months

    Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)

  5. Right ventricular function

    Time frame: 36 months

    Right ventricular strain (%)

  6. NT-proBNP serum concentration (ng/L)

    Time frame: 36 months

    NT-proBNP serum concentration (ng/L)

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

    Time frame: 36 months

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

  8. 6-minute walk distance (meters)

    Time frame: 36 months

  9. All-cause mortality

    Time frame: 36 months

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

    Time frame: 36 months

  11. Number of patients with a rehospitalization due to pacemaker malfunction

    Time frame: 36 months

  12. Number of patients with a rehospitalization due to atrial arrhythmia

    Time frame: 36 months

  13. Number of patients experiencing a stroke or transient ischemic attack

    Time frame: 36 months

  14. Procedure-related complications

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Other

Registry information

Official study title

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

Acronym: AVA CONDUCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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