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

Last updated: September 3, 2024
Sponsor: St. Josefs-Hospital Wiesbaden GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Arrhythmia

Treatment

Cryoballoon pulmonary-vein isolation

Pacemaker implantation and ablation of atrioventricular-node

Clinical Study ID

NCT04906668
ABLATE versus PACE
  • Ages 75-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 tripletherapy 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)

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Cryoballoon pulmonary-vein isolation
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
April 30, 2027

Study 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%).

Connect with a study center

  • Universitätsklinikum Innsbruck

    Innsbruck,
    Austria

    Active - Recruiting

  • Kerckhoff-Klinik Bad Nauheim

    Bad Nauheim,
    Germany

    Active - Recruiting

  • Universitätsklinikum Essen

    Essen,
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt am Main

    Frankfurt,
    Germany

    Site Not Available

  • Klinikum Fürth

    Fürth,
    Germany

    Active - Recruiting

  • Ev. Krankenhaus Hagen-Haspe

    Hagen,
    Germany

    Active - Recruiting

  • Westpfalz-Klinikum Kaiserslautern

    Kaiserslautern,
    Germany

    Active - Recruiting

  • Herz-Zentrum Bodensee

    Konstanz,
    Germany

    Active - Recruiting

  • Krankenhaus Landshut-Achdorf

    Landshut,
    Germany

    Site Not Available

  • St. Marien Hospital Lünen

    Lünen,
    Germany

    Active - Recruiting

  • BG Murnau

    Murnau Am Staffelsee,
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster,
    Germany

    Active - Recruiting

  • St. Josefs-Hospital Wiesbaden GmbH

    Wiesbaden, 65189
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.