Atrial FibrillationNCT04906668
ABLATE Versus PACE: PVI or AV Node Ablation and PM Implantation for Elderly Patients With Persistent AF
A study testing Cryoballoon pulmonary-vein isolation and Pacemaker implantation and ablation of atrioventricular-node in people with Atrial Fibrillation, run by St. Josefs-Hospital Wiesbaden GmbH at 12 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 to 99 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoballoon pulmonary-vein isolation and Pacemaker implantation and ablation of atrioventricular-node
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 May 2021to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Germany11 sites
Kerckhoff-Klinik Bad Nauheim
Bad Nauheim
Vivantes Klinikum am Urban
Berlin
Universitätsklinikum Essen
Essen
Universitätsklinikum Frankfurt am Main
Frankfurt
Klinikum Fürth
Fürth
Ev. Krankenhaus Hagen-Haspe
Hagen
Asklepios Klinik St. Georg
Hamburg
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern
Krankenhaus Landshut-Achdorf
Landshut
Universitätsklinikum Münster
Münster
St. Josefs-Hospital Wiesbaden GmbH
Wiesbaden, 65189
About this study
Official title: 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.
Read the 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
- Being tested
- Cryoballoon pulmonary-vein isolation, Pacemaker implantation and ablation of atrioventricular-node
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon pulmonary-vein isolationProcedure or surgery
Electrical isolation of the pulmonary-veins using cryoenergy
Pacemaker implantation and ablation of atrioventricular-nodeProcedure or surgery
Pacemaker implantation and ablation of atrioventricular-node
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon pulmonary-vein isolation | Active comparator | Not described Receives: Procedure: Cryoballoon pulmonary-vein isolation |
| Ablation of atrioventricular-node and pacemaker implantation | Active comparator | Not described Receives: Procedure: Pacemaker implantation and ablation of atrioventricular-node |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 36 months
Secondary outcomes (8)
Death from any cause
Measured: 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)
Measured: 36 months
Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)
Measured: 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.
Measured: 36 months
Deterioration of systolic LV function ≥10 percent
Measured: 36 months
Number of subjects requiring repeat ablation
Measured: 36 months
Number of subjects requiring anti-arrhythmic drug treatment after initial ablation
Measured: 36 months
Number of nights spent in hospital for occurrence of primary or secondary endpoints
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 May 2021
- Primary completion30 May 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Joachim Ehrlich, MD, Principal investigator, St. Josefs-Hospital Wiesbaden GmbHAndreas Boehmer, MD, Principal investigator, St. Josefs-Hospital Wiesbaden GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906668
- Sponsor's protocol ID
- ABLATE versus PACE
- Status last verified
- Sep 2025
- First submitted
- 19 May 2021
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39067619
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary-vein Isolation or Ablation of Atrioventricular-node and Pacemaker Implantation for Elderly Patients With Persistent Atrial Fibrillation (ABLATE Versus PACE)
- ClinicalTrials.gov ID
- NCT04906668
- Acronym / sponsor ID
- ABLATE versus PACE
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbHUniversity, hospital or other
- Collaborators
- The German Heart Foundation
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon pulmonary-vein isolation | Active comparator | Procedure: Cryoballoon pulmonary-vein isolation |
| Ablation of atrioventricular-node and pacemaker implantation | Active comparator | Procedure: Pacemaker implantation and ablation of atrioventricular-node |
Who may qualify
- Ages
- 75 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoballoon pulmonary-vein isolationElectrical isolation of the pulmonary-veins using cryoenergy | Procedure or surgery | Cryoballoon pulmonary-vein isolation |
| Pacemaker implantation and ablation of atrioventricular-nodePacemaker implantation and ablation of atrioventricular-node | Procedure or surgery | Ablation of atrioventricular-node and pacemaker implantation |
Primary outcome
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
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
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
8 secondary outcomes
Death from any cause
Time frame: 36 months
Number of subjects with procedure-associated complications
Time frame: 36 months
Number of subjects with nonfatal or fatal stroke/ transient ischemic attack (TIA)
Time frame: 36 months
Quality of life as assessed by Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT)
Time frame: 36 months
Deterioration of systolic LV function ≥10 percent
Time frame: 36 months
Number of subjects requiring repeat ablation
Time frame: 36 months
Number of subjects requiring anti-arrhythmic drug treatment after initial ablation
Time frame: 36 months
Number of nights spent in hospital for occurrence of primary or secondary endpoints
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 39067619Boehmer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Ehrlich, MD principal investigator
St. Josefs-Hospital Wiesbaden GmbH
Andreas Boehmer, MD principal investigator
St. Josefs-Hospital Wiesbaden GmbH
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon pulmonary-vein isolation and Pacemaker implantation and ablation of atrioventricular-node in people with Atrial Fibrillation, run by St. Josefs-Hospital Wiesbaden GmbH at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04906668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.