There is evidence of superiority of AV junction ablation strategy over pharmacological therapy only for symptoms of atrial fibrillation, but not for heart failure, hospitalization, morbidity and mortality. Hypothesis of trial is that AV junction ablation is superior to pharmacological therapy as regard hospitalization and mortality
Prospective randomized, controlled, investigator-initiated trial which consists of two specific consecutive(overlapped) phases: "Morbidity trial" (APAF-CRT morbidity). Small size (280 pts), follow-up 24 months. Primary endpoint: combined of mortality due to heartfailure, hospitalization for heart failure or atrial fibrillation or worsening heart failure. Predefined subgroup analysis for patients with ejection fraction ≤35% versus \>35% "Mortality trial" (APAF-CRT mortality). Large size (pts included in morbidity trial plus additional \~1500 pts, long-term follow-up (at least 4 years). Primary endpoint: total mortality. Predefined subgroup analysis for patients with ejection fraction ≤35% versus \>35%
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,830
AV junction ablation
Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)
Optimized drug therapy for heart failure and atrial fibrillation rate control
Department of Cardiology, Ospedali del Tigullio
Lavagna, Italy
RECRUITINGCombined end-point
"Morbidity trial" end-points Primary end-point: a combined of (1) mortality due to heart failure, (2) hospitalization for heart failure or uncontrolled intolerable atrial fibrillation, or (3) worsening heart failure
Time frame: Upto 3 years
Major clinical events
"Morbidity trial" end-points Secondary end-points: total mortality, total hospitalizations, hospitalization for heart failure and/or atrial fibrillation and worsening heart failure.
Time frame: Up to 3 years
Major clinical events
"Mortality trial" end-points Secondary end-point: cardiovascular mortality and hospitalization for heart failure or uncontrolled intolerable atrial fibrillation
Time frame: Up to 5 years
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Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines