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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Cryoballoon pulmonary-vein isolation; Procedure: Pacemaker implantation and ablation of atrioventricular-node

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 Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Universitätsklinikum Innsbruck
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff-Klinik Bad Nauheim
  • Berlin, Germany
    • Vivantes Klinikum Am Urban
  • Essen, Germany
    • Universitätsklinikum Essen
  • Frankfurt, Germany
    • Universitätsklinikum Frankfurt am Main
  • Fürth, Germany
    • Klinikum Furth
  • Hagen, Germany
    • Ev. Krankenhaus Hagen-Haspe
  • Hamburg, Germany
    • Asklepios Klinik St. Georg
  • Kaiserslautern, Germany
    • Westpfalz-Klinikum Kaiserslautern
  • Landshut, Germany
    • Krankenhaus Landshut-Achdorf
  • Münster, Germany
    • Universitätsklinikum Münster
  • Wiesbaden, Germany, 65189
    • St. Josefs-Hospital Wiesbaden GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cryoballoon pulmonary-vein isolation	Procedure: Cryoballoon pulmonary-vein isolation; Electrical isolation of the pulmonary-veins using cryoenergy
Active Comparator: Ablation of atrioventricular-node and pacemaker implantation	Procedure: Pacemaker implantation and ablation of atrioventricular-node; Pacemaker implantation and ablation of atrioventricular-node

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with any hospitalization due to atrial fibrillation, atrial tachycardia or flutter after blanking period or cardiac decompensation requiring inpatient treatment	except for protocol-indicated AVN ablation	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		36 months
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		36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death from any cause		36 months
Number of subjects with procedure-associated complications	(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)	36 months
Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)		36 months
Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)	Scale 20-140 with higher score indicating worse quality-of-life.	36 months
Deterioration of systolic LV function ≥10 percent		36 months
Number of subjects requiring repeat ablation		36 months
Number of subjects requiring anti-arrhythmic drug treatment after initial ablation		36 months
Number of nights spent in hospital for occurrence of primary or secondary endpoints		36 months

Collaborators and Investigators

• Sponsor: St. Josefs-Hospital Wiesbaden GmbH
• Collaborators: The German Heart Foundation
• Investigators: Principal Investigator: Joachim Ehrlich, MD, St. Josefs-Hospital Wiesbaden GmbH; Principal Investigator: Andreas Boehmer, MD, St. Josefs-Hospital Wiesbaden GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: ABLATE versus PACE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No