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

St. Josefs-Hospital Wiesbaden GmbH

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: Pacemaker implantation and ablation of atrioventricular-node; Procedure: Cryoballoon pulmonary-vein isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT04906668

ABLATE versus PACE

Details and patient eligibility

About

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.

Full description

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%).

Enrollment: 196 estimated patients

Sex: All

Ages: 75 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persistent AF according to current ESC guideline (2020)
• Symptoms EHRA classification II - IV despite guideline indicated medical therapy
• Age ≥ 75 years
• Capability of giving written informed consent

Exclusion criteria

• impaired systolic left ventricular function (ejection fraction < 50%)
• High-grade (III°) left cardiac valvular disease
• pre-implanted pacemaker
• bradycardia-indication for pacemaker
• Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
• contraindication for PVI or pacemaker-implantation
• contraindication for oral anticoagulation
• body-mass-index BMI > 40 kg/m2
• inability to give written informed consent
• concomitant participation in another registered trial
• life expectancy < 12 months
• reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Cryoballoon pulmonary-vein isolation

Active Comparator group

Treatment:

Procedure: Cryoballoon pulmonary-vein isolation

Ablation of atrioventricular-node and pacemaker implantation

Active Comparator group

Treatment:

Procedure: Pacemaker implantation and ablation of atrioventricular-node