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NCT Number: NCT04906668

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

75 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Innsbruck, Innsbruck, Austria

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About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cryoballoon pulmonary-vein isolation

Procedure

Electrical isolation of the pulmonary-veins using cryoenergy

Pacemaker implantation and ablation of atrioventricular-node

Procedure

Pacemaker implantation and ablation of atrioventricular-node

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Death from any cause

    Time frame: 36 months

  2. Number of subjects with procedure-associated complications

    Time frame: 36 months

    (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)

  3. Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)

    Time frame: 36 months

  4. Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)

    Time frame: 36 months

    Scale 20-140 with higher score indicating worse quality-of-life.

  5. Deterioration of systolic LV function ≥10 percent

    Time frame: 36 months

  6. Number of subjects requiring repeat ablation

    Time frame: 36 months

  7. Number of subjects requiring anti-arrhythmic drug treatment after initial ablation

    Time frame: 36 months

  8. Number of nights spent in hospital for occurrence of primary or secondary endpoints

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Other

Collaborators

  • The German Heart Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
May 28, 2021
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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