RecruitingNot ApplicableNCT05776797
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Sponsor
University Hospital Ostrava
Enrollment
480 participants
Start Date
Apr 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria6
- 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 Criteria6
- 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)
Interventions
PROCEDUREAtrioventricular 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).
DRUGOptimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Optimal medication therapy according to the prescription of the physician.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05776797
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