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)
1 other identifier
interventional
196
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started May 2021
Longer than P75 for not_applicable atrial-fibrillation
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
September 17, 2025
September 1, 2025
5.1 years
May 19, 2021
September 11, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
Death from any cause
36 months
Number of subjects with procedure-associated complications
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)
36 months
Deterioration of systolic LV function ≥10 percent
36 months
- +3 more secondary outcomes
Study Arms (2)
Cryoballoon pulmonary-vein isolation
ACTIVE COMPARATORAblation of atrioventricular-node and pacemaker implantation
ACTIVE COMPARATORInterventions
Electrical isolation of the pulmonary-veins using cryoenergy
Pacemaker implantation and ablation of atrioventricular-node
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Josefs-Hospital Wiesbaden GmbHlead
- The German Heart Foundationcollaborator
Study Sites (12)
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, 65189, Germany
Related Publications (1)
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.
PMID: 39067619BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joachim Ehrlich, MD
St. Josefs-Hospital Wiesbaden GmbH
- PRINCIPAL INVESTIGATOR
Andreas Boehmer, MD
St. Josefs-Hospital Wiesbaden GmbH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 28, 2021
Study Start
May 1, 2021
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
September 17, 2025
Record last verified: 2025-09