ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients With Persistent AF

Condition(s) studied

Investigational drug(s) / intervention(s)

Cryoballoon pulmonary-vein isolation: Electrical isolation of the pulmonary-veins using cryoenergy

Pacemaker implantation and ablation of atrioventricular-node: Pacemaker implantation and ablation of atrioventricular-node

Study summary

As patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ABLATE versus PACE is a prospective, randomized clinical trial comparing pacemaker implantation with AV node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent AF aged 75 years and older.

Eligibility

Primary outcome measure(s)

• Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment — 36 months
  except for protocol-indicated AVN ablation
• Number of subjects requiring repeat ablation, electrical or pharmacological cardioversion for symptomatic relapse of atrial fibrillation, atrial tachycardia or flutter after blanking period — 36 months
• Number of subjects requiring upgrade to cardiac resynchronization therapy pacemaker due to reduced systolic left ventricular function with ejection fraction ≤35% in "ablate-and-pace" group — 36 months

Trial sites (12)

Other trials for the same condition