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Recruiting NCT07428967

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

No phase Interventional Atrial Fibrillation Atrial Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RV pacing, LBBA pacing.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Atrial Arrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Procedure RV pacing
    RV apical pacemaker implantation prior to AV node ablation
  • Procedure LBBA pacing
    LBBA pacemaker implantation prior to AV node ablation

Primary outcome measures

  • Number of patients developing pacemaker-induced cardiomyopathy [Time frame: 36 months]
Secondary outcome measures (12)
  • Left ventricular function [Time frame: 36 months]
  • Left Ventricular Global Longitudinal Strain [Time frame: 36 months]
  • Right ventricular function [Time frame: 36 months]
  • Right ventricular function [Time frame: 36 months]
  • Right ventricular function [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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 2 centers
  • Evangelisches Krankenhaus Hagen-Haspe — Hagen
  • St. Josefs-Hospital Wiesbaden GmbH — Wiesbaden

Identifiers

NCT: NCT07428967 · AVA CONDUCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗