AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Recruiting · NCT05776797 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Ostrava
View the official record on ClinicalTrials.gov →Interventions studied
Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
What this trial is about
A study comparing atrioventricular junction ablation (AVJA) versus continued optimum medical rate control in patients with cardiac resynchronization therapy (CRT) and atrial fibrillation (AF) with suboptimal heart rate control on optimum medication.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
9 locations listed.
- Institute of Clinical and Experimental Medicine - Prague, Czechia
- Military University Hospital Prague - Prague, Czechia
- Regional Hospital Liberec - Liberec, Liberec Region, Czechia
- University Hospital Ostrava - Ostrava, Moravian-Silesian Region, Czechia
- Hospital Podlesí, Inc. - Třinec, Moravian-Silesian Region, Czechia
- University Hospital Olomouc - Olomouc, Olomouc Region, Czechia
- Hospital České Budějovice - České Budějovice, South Bohemian Region, Czechia
- St. Anne's University Hospital Brno - Brno, South Moravian, Czechia
- University Hospital Brno - Brno, South Moravian, Czechia