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Clinical Trials/NCT04906668
NCT04906668Active, not recruitingNot Applicable

Pulmonary-vein Isolation or Ablation of Atrioventricular-node and Pacemaker Implantation for Elderly Patients With Persistent Atrial Fibrillation (ABLATE Versus PACE)

St. Josefs-Hospital Wiesbaden GmbH20 sites in 2 countries196 target enrollmentStarted: May 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
196
Locations
20
Primary Endpoint
Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment

Study Overview

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%).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
75 Years to 99 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment

Time Frame: 36 months

except for protocol-indicated AVN ablation

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

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

Secondary Outcomes

  • Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)(36 months)
  • Deterioration of systolic LV function ≥10 percent(36 months)
  • Number of subjects with procedure-associated complications(36 months)
  • Death from any cause(36 months)
  • Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)(36 months)
  • Number of subjects requiring anti-arrhythmic drug treatment after initial ablation(36 months)
  • Number of subjects requiring repeat ablation(36 months)
  • Number of nights spent in hospital for occurrence of primary or secondary endpoints(36 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (20)

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