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

February 17, 2026 updated by: St. Josefs-Hospital Wiesbaden GmbH

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:
        • Principal Investigator:
          • Joachim Ehrlich, MD
        • Principal Investigator:
          • Andreas Boehmer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 36 months

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
Time Frame: 36 months
Left ventricular ejection fraction (%)
36 months
Left Ventricular Global Longitudinal Strain
Time Frame: 36 months
Global longitudinal strain of the left ventricle (%)
36 months
Right ventricular function
Time Frame: 36 months
Tricuspid Annular Plane Systolic Excursion (mm)
36 months
Right ventricular function
Time Frame: 36 months
Right Ventricle - Pulmonary Artery Coupling (mm/mmHg)
36 months
Right ventricular function
Time Frame: 36 months
Right ventricular strain (%)
36 months
NT-proBNP serum concentration (ng/L)
Time Frame: 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
Time Frame: 36 months
Ranging from 0 to 100 with higher scores represent a better outcome.
36 months
6-minute walk distance (meters)
Time Frame: 36 months
36 months
All-cause mortality
Time Frame: 36 months
36 months
Number of patients with a rehospitalization due to heart failure/cardiac decompensation
Time Frame: 36 months
36 months
Number of patients with a rehospitalization due to pacemaker malfunction
Time Frame: 36 months
36 months
Number of patients with a rehospitalization due to atrial arrhythmia
Time Frame: 36 months
36 months
Number of patients experiencing a stroke or transient ischemic attack
Time Frame: 36 months
36 months
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)
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Josefs-Hospital Wiesbaden GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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