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

NCT ID: NCT04906668

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2027-04-30

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%).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoballoon pulmonary-vein isolation

Group Type: ACTIVE_COMPARATOR

Cryoballoon pulmonary-vein isolation

Intervention Type: PROCEDURE

Electrical isolation of the pulmonary-veins using cryoenergy

Ablation of atrioventricular-node and pacemaker implantation

Group Type: ACTIVE_COMPARATOR

Pacemaker implantation and ablation of atrioventricular-node

Intervention Type: PROCEDURE

Pacemaker implantation and ablation of atrioventricular-node

Interventions

Cryoballoon pulmonary-vein isolation

Electrical isolation of the pulmonary-veins using cryoenergy

Intervention Type: PROCEDURE

Pacemaker implantation and ablation of atrioventricular-node

Pacemaker implantation and ablation of atrioventricular-node

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The German Heart Foundation

OTHER

Sponsor Role: collaborator

St. Josefs-Hospital Wiesbaden GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Ehrlich, MD

Role: PRINCIPAL_INVESTIGATOR

St. Josefs-Hospital Wiesbaden GmbH

Andreas Boehmer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Josefs-Hospital Wiesbaden GmbH

Locations

Universitätsklinikum Innsbruck

Innsbruck, , Austria

Kerckhoff-Klinik Bad Nauheim

Bad Nauheim, , Germany

Vivantes Klinikum am Urban

Berlin, , Germany

Universitätsklinikum Essen

Essen, , Germany

Universitätsklinikum Frankfurt am Main

Frankfurt, , Germany

Klinikum Fürth

Fürth, , Germany

Ev. Krankenhaus Hagen-Haspe

Hagen, , Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, , Germany

Krankenhaus Landshut-Achdorf

Landshut, , Germany

Universitätsklinikum Münster

Münster, , Germany

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, , Germany

Countries

Austria; Germany

References

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.

Reference Type: BACKGROUND

PMID: 39067619 (View on PubMed)

Other Identifiers

ABLATE versus PACE

Identifier Type: -

Identifier Source: org_study_id