Actively Recruiting
Study of Atrioventricular Junction Ablation versus Optimal Medication for Patients With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Led by University Hospital Ostrava · Updated on 2023-06-08
480
Participants Needed
9
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare atrioventricular junction ablation AVJA with continued optimal medication treatment for patients who have cardiac resynchronization therapy CRT and permanent or recurrent persistent atrial fibrillation AF with suboptimal heart rate control despite optimal medication. The study will randomly assign participants to one of two groups to evaluate which approach better manages heart function and quality of life over time. Participants will be randomly divided into two groups in equal numbers. One group will undergo AVJA, a procedure that disrupts the electrical connection between the upper and lower chambers of the heart, performed soon after randomization and repeated if necessary. The other group will continue with optimal medication treatment prescribed by their physician. CRT devices will be programmed uniformly with a base rate of 70 bpm and rate response functions activated unless not tolerated. Throughout the study, all participants will be regularly monitored at outpatient clinics. Researchers will assess heart failure events, quality of life using standardized questionnaires, medication doses, and heart function classification over a 3-year period. Secondary outcomes include mortality rates, heart failure hospitalizations, blood biomarker changes, and hospitalization days. Participants may switch from medication to AVJA if clinical deterioration occurs. The total study duration extends to 3 years with comprehensive follow-up to track these outcomes.
CONDITIONS
Brief Title
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Research Team
J
Jiří Hynčica
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