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.
Atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk. In case of recurrent symptomatic atrial fibrillation current guidelines recommend pulmonary-vein isolation (PVI) as invasive treatment option. However, 5-year arrhythmia-free survival estimate is 29% after single catheter ablation. Although the long-term success rates in maintaining sinus rhythm are higher than with drug-based rhythm control, they are still moderate, especially in older patients with comorbidities. Therefore, repeated interventions are often necessary. An effective method for frequency control is atrioventricular (AV) node ablation after implantation of a pacemaker ("ablate-and-pace"). In this case, the ventricular rate is only set by the pacemaker and can be programmed according to the patient's needs. There are some theoretical disadvantages of this treatment option (pacemaker dependency, reduction of cardiac outpout due to lack of atrial contraction) which is why this method nowadays is almost exclusively used in older (and physically less active) patients. The ABLATE versus PACE trial is a prospective randomized clinical trial comparing at 196 these two treatment options in terms of rehospitalizations due to cardiovascular causes and quality of life in elderly patients (≥ 75 years) with normal ejection fraction (≥ 50%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Electrical isolation of the pulmonary-veins using cryoenergy
Pacemaker implantation and ablation of atrioventricular-node
Universitätsklinikum Innsbruck
Innsbruck, Austria
Kerckhoff-Klinik Bad Nauheim
Bad Nauheim, Germany
Vivantes Klinikum am Urban
Berlin, Germany
Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment
except for protocol-indicated AVN ablation
Time frame: 36 months
Number of subjects requiring repeat ablation, electrical or pharmacological cardioversion for symptomatic relapse of atrial fibrillation, atrial tachycardia or flutter after blanking period
Time frame: 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
Time frame: 36 months
Death from any cause
Time frame: 36 months
Number of subjects with procedure-associated complications
(major bleeding by Bleeding Academic Research Consortium Definition (BARC ≥ 2) criteria, major groin site complications prolonging inpatient stay, pacemaker pocket bleeding prolonging inpatient stay, pericardial effusion, cerebrovascular or systemic embolism, phrenic nerve palsy, lead dislodgment, lead perforation, infection including pacemaker pocket infection, lead infection / pacemaker related endocarditis)
Time frame: 36 months
Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)
Time frame: 36 months
Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)
Scale 20-140 with higher score indicating worse quality-of-life.
Time frame: 36 months
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Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Frankfurt am Main
Frankfurt, Germany
Klinikum Fürth
Fürth, Germany
Ev. Krankenhaus Hagen-Haspe
Hagen, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern, Germany
Krankenhaus Landshut-Achdorf
Landshut, Germany
...and 2 more locations
Deterioration of systolic LV function ≥10 percent
Time frame: 36 months
Number of subjects requiring repeat ablation
Time frame: 36 months
Number of subjects requiring anti-arrhythmic drug treatment after initial ablation
Time frame: 36 months
Number of nights spent in hospital for occurrence of primary or secondary endpoints
Time frame: 36 months