Comparing atrioventricular junction ablation and medication for patients with heart failure and atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of atrioventricular junction ablation (AVJA) versus optimal medical treatment in patients with cardiac resynchronization therapy (CRT) who have persistent or recurrent atrial fibrillation (AF) and inadequate heart rate control. Patients will be randomly assigned to either the intervention group receiving AVJA or the control group continuing medication. The CRT device will be programmed to maintain a base heart rate, and patients will be monitored regularly in outpatient clinics. If patients experience clinical deterioration, they may cross over to the AVJA group during the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Treatment with CRT using either a biventricular pacemaker/defibrillator or conduction system pacemaker (\>6 months)
* Diagnosis of AF and classified as: permanent AF or recurrent persistent AF, requiring emergency visits and/or hospitalizations (at least one in recent year)
* Optimized HF medical treatment and rate control medication
* BiVP% + ventricular premature complex (VPC%) \<99% and \>85% during the minimum period of 1 month while already on optimum medical therapy (applicable only for patients with permanent AF)
* Age \>18 and \<85 years
* Signed informed consent

Exclusion Criteria:

* myocardial infarction (MI) or coronary artery bypass graft (CABG) \<3 months
* Technical failure of the CRT system
* Intentional preference for spontaneous AV conduction
* Expected survival \<1 year
* Other significant comorbidities and/or conditions that interfere with the proper conduction of the trial
* Dementia as assessed by mini-mental test (\<23 points)

Where it's running

• Regional Hospital Liberec
  Liberec, Liberec Region, Czechia Recruiting
• University Hospital Ostrava
  Ostrava, Moravian-Silesian Region, Czechia Recruiting
• Hospital Podlesí, Inc.
  Třinec, Moravian-Silesian Region, Czechia Recruiting
• University Hospital Olomouc
  Olomouc, Olomouc Region, Czechia Recruiting
• Hospital České Budějovice
  České Budějovice, South Bohemian Region, Czechia Recruiting
• St. Anne's University Hospital Brno
  Brno, South Moravian, Czechia Recruiting

Study contacts

• Principal investigator: Jiří Plášek, MD,PhD,FESC — University Hospital Ostrava
• Study coordinator: Jiří Hynčica
• Email: jiri.hyncica@fno.cz
• Phone: 0042059737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.