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ID05776797

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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