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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Treatment with cardiac resynchronization therapy (CRT) using a biventricular pacemaker, defibrillator, or conduction system pacemaker for more than 6 months
Diagnosis of permanent atrial fibrillation (AF) or recurrent persistent AF requiring emergency visits or hospitalizations at least once in the past year
Optimized heart failure (HF) medical treatment and rate control medication
For permanent AF patients, biventricular pacing plus ventricular premature complex percentage between 85% and less than 99% during at least 1 month on optimal medication
Age between 18 and 85 years
Signed informed consent
You will not qualify if you...
Myocardial infarction or coronary artery bypass graft surgery within the last 3 months
Technical failure of the CRT system
Intentional preference for spontaneous atrioventricular conduction
Expected survival less than 1 year
Other significant comorbidities or conditions interfering with the trial
Dementia with mini-mental test score below 23 points
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 years
Participants are randomly assigned to receive either atrioventricular junction ablation or optimal medication treatment for their cardiac condition.
Regular outpatient visits during treatment
Follow-up
Duration - Up to 3 years
Participants are regularly followed in outpatient clinics for monitoring of heart failure events, quality of life, and other health outcomes after treatment.
Regular outpatient visits during follow-up
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The Benefit of Atrioventricular Junction Ablation for Permanent Atrial Fibrillation and Heart Failure Patients Receiving Cardiac Resynchronization Therapy: An Updated Systematic Review and Meta-analysis.
Development and Evolution of a Hierarchical Clinical Composite End Point for the Evaluation of Drugs and Devices for Acute and Chronic Heart Failure: A 20-Year Perspective.
Heart failure decompensation and all-cause mortality in relation to percent biventricular pacing in patients with heart failure: is a goal of 100% biventricular pacing necessary?