Comparing atrioventricular junction ablation and medication for patients with heart failure and atrial fibrillation
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
This study is testing whether a procedure called atrioventricular junction ablation can help people with heart failure and atrial fibrillation feel better compared to just using medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 9 sites (Liberec, Liberec Region and 8 other locations) |
| Trial ID | NCT05776797 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with permanent or recurrent persistent atrial fibrillation who have been on optimized heart failure medication and CRT for over six months.
Not a fit: Patients with recent myocardial infarction, significant comorbidities, or those preferring spontaneous AV conduction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve heart rate control and overall quality of life for patients with atrial fibrillation and heart failure.
How similar studies have performed: Other studies have shown promising results with atrioventricular junction ablation in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Liberec, Liberec Region and 8 other locations
- 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)
- University Hospital Brno — Brno, South Moravian, Czechia (Recruiting)
- Institute of Clinical and Experimental Medicine — Prague, Czechia (Recruiting)
- Military University Hospital Prague — Prague, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.