Heart FailurePACE-FIBNCT05029570
Heart Rate Regularization in Atrial Fibrilation and Heart Failure
A study testing Conduction System Pacing (pacemaker implantation) in people with Heart Failure and Atrial Fibrillation, run by Daniel Rodríguez Muñoz at 1 site in Spain.
Trial summary
The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level>900 pg/ml will be randomised to either… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Atrial Fibrillation
- What is being tested?
- Conduction System Pacing (pacemaker implantation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteSpain
- Study dates
- 29 Apr 2022to Sep 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Permanent atrial fibrillation
- At least one episode of hospitalisation due to heart failure in the previous 12 months.
- Left ventricular ejection fraction > 40%
- Average resting heart rate ≤ 110 beats per minute
- NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
- Age ≥ 18 years
- Capacity to understand the nature of the study, legal ability and willingness to give informed consent.
Who cannot join
- Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to < 12 months.
- Acute heart failure at the time of enrollment or systolic blood pressure < 80 mmHg in the absence of inotropic agents.
- Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
- Severe mitral or aortic valvular heart disease
- Anaemia (Haemoglobin < 10 g/dl)
- Morbid obesity (BMI ≥ 35)
Show all 11Show fewer
- Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3)
- Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD)
- Obstructive hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
- Simultaneous participation in a different trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Daniel Rodríguez Muñoz, MD, PhD, +34 917792742, danielantonio.rodriguez@salud.madrid.org
About this study
Official title: Conduction System PACing and Atrioventricular Node Ablation in Patients With hEart Failure, Left Ventricular Ejection Fraction >40% and Permanent Atrial FIBrilation: the PACE-FIB Trial
The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.
Read the detailed description
Permanent atrial fibrillation (AF) causes beat-to-beat heart rate irregularity, which has shown to decrease cardiac output. Observational data suggest that heart rate regularization through atrioventricular (AV) node ablation and pacemaker implantation improves outcomes in heart failure (HF) patients. However, no trials have been conducted to assess its potential benefit in HF and left ventricular ejection fraction (LVEF)>40%, a population in whom treatment strategies effectively improving outcomes are scarce.
The goal of this trial is to assess the benefit of heart rate regularization through AV node ablation and conduction system pacing (CSP) in patients with permanent AF and HF with preserved or mildly reduced systolic function. The investigators hypothesize that heart rate regularization added to physiological pacing - preventing the deleterious effect of right apical pacing - reduces mortality, HF hospitalisations or worsening HF in these patients.
- Conditions
- Heart Failure, Atrial Fibrillation
- Being tested
- Conduction System Pacing (pacemaker implantation)
- Keywords
- atrial fibrillation;, heart failure;, conduction system pacing;, heart rate regularization
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conduction System Pacing (pacemaker implantation)Device
Also called Atrioventricular node ablation
Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation
| Study group | Role | What they receive |
|---|---|---|
| Conduction System Pacing and AV node ablation | Experimental | Atrioventricular node ablation and subsequent conduction system pacing Receives: Device: Conduction System Pacing (pacemaker implantation) |
| Medical treatment for rate control of AF | No intervention | Pharmacological rate control based on clinical practice guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint
All-cause mortality, heart failure hospitalisation and worsening heart failure
Measured: 36 months
Secondary outcomes (11)
All-cause mortality
Mortality due to any cause
Measured: 36 months
Cardiovascular mortality
Mortality due to cardiovascular causes
Measured: 36 months
Heart failure hospitalization
Hospitalization due to heart failure decompensation
Measured: 36 months
Worsening heart failure
An episode of heart failure diagnosed based on symptoms, signs, imaging and analytical criteria that requires unplanned medical attention and intravenous diuretic therapy
Measured: 36 months
Unplanned cardiovascular hospitalisation
Unplanned cardiovascular hospitalisation
Measured: 36 months
Left ventricular ejection fraction
assessed by the Simpson method
Measured: 12 months
Change in left ventricular dimension
end-diastolic and end-systolic volumes
Measured: 12 months
Change in degree of mitral regurgitation
Change in degree of mitral regurgitation
Measured: 12 months
Change in functional status
Assessed by New York Heart Association (NYHA) on a I to IV scale (I being better functional status and IV worst possible functional status)
Measured: 36 months
Major adverse events during or in the first 30-days following pacemaker implantation
Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, pneumothorax, haemothorax, device infection, endocarditis, lead displacement requiring re-intervention
Measured: 30 days
Major adverse events during or in the first 30-days following atrioventricular node ablation
Percentage of patients suffering one of the following: death, cardiac tamponade, perforation requiring cardiac surgery, puncture site vascular complications requiring vascular surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start29 Apr 2022
- Primary completion31 Jul 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Model description
- Medical Device: Conduction System Pacing (pacemaker implantation)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Rodríguez Muñoz
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Castellana de Cardiologia
- Responsible party
- Sponsor-investigator, Daniel Rodríguez Muñoz, Hospital Universitario 12 de Octubre
- Investigators
- Fernando Arribas Ynsaurriaga, MD, PhD, Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029570
- Sponsor's protocol ID
- PACE-FIB
- Acronym
- PACE-FIB
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2021
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System PACing and Atrioventricular Node Ablation in Patients With hEart Failure, Left Ventricular Ejection Fraction >40% and Permanent Atrial FIBrilation: the PACE-FIB Trial
- ClinicalTrials.gov ID
- NCT05029570
- Acronym / sponsor ID
- PACE-FIB / PACE-FIB
- Conditions
- Heart Failure, Atrial Fibrillation
- Keywords
- atrial fibrillation;, heart failure;, conduction system pacing;, heart rate regularization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Daniel Rodríguez MuñozUniversity, hospital or other
- Collaborators
- Sociedad Castellana de Cardiologia
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 31 Aug 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.
The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.
Detailed description
Permanent atrial fibrillation (AF) causes beat-to-beat heart rate irregularity, which has shown to decrease cardiac output. Observational data suggest that heart rate regularization through atrioventricular (AV) node ablation and pacemaker implantation improves outcomes in heart failure (HF) patients. However, no trials have been conducted to assess its potential benefit in HF and left ventricular ejection fraction (LVEF)>40%, a population in whom treatment strategies effectively improving outcomes are scarce.
The goal of this trial is to assess the benefit of heart rate regularization through AV node ablation and conduction system pacing (CSP) in patients with permanent AF and HF with preserved or mildly reduced systolic function. The investigators hypothesize that heart rate regularization added to physiological pacing - preventing the deleterious effect of right apical pacing - reduces mortality, HF hospitalisations or worsening HF in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Medical Device: Conduction System Pacing (pacemaker implantation)
| Arm | Type | Receives |
|---|---|---|
| Conduction System Pacing and AV node ablation | Experimental | Device: Conduction System Pacing (pacemaker implantation)Atrioventricular node ablation and subsequent conduction system pacing |
| Medical treatment for rate control of AF | No intervention | –Pharmacological rate control based on clinical practice guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Permanent atrial fibrillation
- At least one episode of hospitalisation due to heart failure in the previous 12 months.
- Left ventricular ejection fraction > 40%
- Average resting heart rate ≤ 110 beats per minute
- NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
Key exclusion criteria (11 listed)
- Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to < 12 months.
- Acute heart failure at the time of enrollment or systolic blood pressure < 80 mmHg in the absence of inotropic agents.
- Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
- Severe mitral or aortic valvular heart disease
- Anaemia (Haemoglobin < 10 g/dl)
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 |
|---|---|---|
| Conduction System Pacing (pacemaker implantation)Also: Atrioventricular node ablationConduction System Pacing (pacemaker implantation) and Atrioventricular node ablation | Device | Conduction System Pacing and AV node ablation |
Primary outcome
Composite primary endpoint
Time frame: 36 months
All-cause mortality, heart failure hospitalisation and worsening heart failure
11 secondary outcomes
All-cause mortality
Time frame: 36 months
Cardiovascular mortality
Time frame: 36 months
Heart failure hospitalization
Time frame: 36 months
Worsening heart failure
Time frame: 36 months
Unplanned cardiovascular hospitalisation
Time frame: 36 months
Left ventricular ejection fraction
Time frame: 12 months
Change in left ventricular dimension
Time frame: 12 months
Change in degree of mitral regurgitation
Time frame: 12 months
Change in functional status
Time frame: 36 months
Major adverse events during or in the first 30-days following pacemaker implantation
Time frame: 30 days
Major adverse events during or in the first 30-days following atrioventricular node ablation
Time frame: 30 days
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 9 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Fernando Arribas Ynsaurriaga, MD, PhD study chair
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conduction System Pacing (pacemaker implantation) in people with Heart Failure and Atrial Fibrillation, run by Daniel Rodríguez Muñoz at 1 site in Spain.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 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 1 site in Spain. 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?
Contact Daniel Rodriguez Muñoz, MD, PhD (+34 917792742, danielantonio.rodriguez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.