Clinical trial NCT04906668: ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients with Persistent AF
Official title: Pulmonary-vein Isolation or Ablation of Atrioventricular-node and Pacemaker Implantation for Elderly Patients with Persistent Atrial Fibrillation (ABLATE Versus PACE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: St. Josefs-Hospital Wiesbaden GmbH
Sponsor class: OTHER
Collaborators: name: The German Heart Foundation
First posted: 2021-05-28
Enrollment: 196
Sex: ALL
Minimum age (years): 75
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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%).

Eligibility criteria: 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)

Primary outcomes:
measure: Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment
timeFrame: 36 months
measure: Number of subjects requiring repeat ablation, electrical or pharmacological cardioversion for symptomatic relapse of atrial fibrillation, atrial tachycardia or flutter after blanking period
timeFrame: 36 months
measure: 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
timeFrame: 36 months
Secondary outcomes:
measure: Death from any cause
timeFrame: 36 months
measure: Number of subjects with procedure-associated complications
timeFrame: 36 months
measure: Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)
timeFrame: 36 months
measure: Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)
timeFrame: 36 months
measure: Deterioration of systolic LV function ≥10 percent
timeFrame: 36 months
measure: Number of subjects requiring repeat ablation
timeFrame: 36 months
measure: Number of subjects requiring anti-arrhythmic drug treatment after initial ablation
timeFrame: 36 months
measure: Number of nights spent in hospital for occurrence of primary or secondary endpoints
timeFrame: 36 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik Bad Nauheim
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt am Main
city: Fürth
country: Germany
facility: Klinikum Fürth
city: Hagen
country: Germany
facility: Ev. Krankenhaus Hagen-Haspe
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum Kaiserslautern
city: Konstanz
country: Germany
facility: Herz-Zentrum Bodensee
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Lünen
country: Germany
facility: St. Marien Hospital Lünen
city: Murnau Am Staffelsee
country: Germany
facility: BG Murnau
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden GmbH
Study officials:
affiliation: St. Josefs-Hospital Wiesbaden GmbH
name: Joachim Ehrlich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Josefs-Hospital Wiesbaden GmbH
name: Andreas Boehmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boehmer AA, Kaess BM, Ruckes C, Meyer C, Metzner A, Rillig A, Eckardt L, Nattel S, Ehrlich JR; ABLATE Versus PACE Investigators. Pulmonary Vein Isolation or Pace and Ablate in Elderly Patients With Persistent Atrial Fibrillation (ABLATE Versus PACE)-Rationale, Methods, and Design. Can J Cardiol. 2024 Dec;40(12):2429-2440. doi: 10.1016/j.cjca.2024.07.021. Epub 2024 Jul 25.