RECRUITINGINTERVENTIONAL
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
PROCEDURE
Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)
Ablation of the atrioventricular (AV) node is a procedure used to disrupt or break the electrical connection between the upper heart chambers (the atria) and the lower heart chambers (the ventricles).
DRUG
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Optimal medication therapy according to the prescription of the physician.
Locations (9)
Hospital České Budějovice
České Budějovice, Jihočeský kraj, 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
St. Anne's University Hospital Brno
Brno, South Moravian, Czechia
University Hospital Brno
Brno, South Moravian, Czechia
Institute of Clinical and Experimental Medicine
Prague, Czechia
Military University Hospital Prague
Prague, Czechia