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AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation

NCT07604727 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2026-05-22

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if conduction system pacing works as well as cardiac resynchronization therapy (CRT) post atrioventricular (AV) node ablation in adult patients with symptomatic heart failure and atrial fibrillation that is not suitable for rhythm control.

The main question it aims to answer is:

Is AV node ablation with conduction system pacing noninferior to AV node ablation with CRT for the hierarchical composite outcome of all-cause mortality, heart failure hospitalization or urgent heart failure visit, and meaningful improvement in heart failure-related quality of life?

Participants will undergo:

* An AV node ablation and be randomly assigned to receive either a conduction system pacing or a CRT.
* Attend follow-up visits (in clinic or by telephone) at baseline, intervention day, 3-month, 12-month, 24-month, and 36-month after the procedure.
* Complete questionnaires about heart failure symptoms and quality of life at baseline, 12 months, and yearly.
* Have an echocardiogram, an electrocardiogram, and blood tests at baseline and 1 year
* At selected centers: they will be asked to wear a bracelet that measures arterial stiffness for 30 minutes and provide a urine sample at baseline and 1 year.

Conditions

Interventions

PROCEDURE

Conduction System Pacing

The implantation of a pacing device with a pacing lead that aims to capture and pace the native conduction system.

PROCEDURE

Cardiac resynchronization therapy

The implantation of a pacing device with a pacing leads that aims to capture and pace both ventricles in a synchronized fashion, to achieve the best possible hemodynamic parameters and synchrony.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Michiel Rienstra, MD, PhD, MHA, Professor · University Medical Center Groningen, Groningen, The Netherlands

  • Yuri Blaauw, MD, PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-06-30
Completion
2030-06-30

Countries

  • France
  • Germany
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604727 on ClinicalTrials.gov