An interventional study of pacemaker implantation and atrioventricular node ablation in Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation, Persistent, sponsored by French Cardiology Society. Recruiting at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by French Cardiology Society · Not applicable, Interventional, and Treatment
Among 317 studies in Atrial Fibrillation with a site in France — 63 open to participants now, 87 under way, 5 of them phase 3. Atrial Fibrillation · France.
Among the 317 studies in Atrial Fibrillation with a site in France, this one is the 91st largest by planned enrollment of the 193 interventional ones that give a count, is one of 11 that started in 2025, is one of 117 with no phase, reaches primary completion later than 74 of the 86 other live ones, and was the 293rd registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
Browse Atrial Fibrillation studies →63 of the 317 studies in Atrial Fibrillation with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire Dijon · Sites in France
Poitiers University Hospital · Sites in France
Volta Medical · Sites in France
Oslo University Hospital · Sites in France, United States, Belgium and 7 more countries
Boston Scientific Corporation · Sites in France, Belgium, Croatia and 2 more countries
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
317 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 12 · Phase 3 42 · Phase 4 24
First in 1999; this study’s year is marked. 11 started in 2025.
This study's planned enrollment of 266 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Median enrollment 250 across the 193 interventional studies, 250 across the 123 observational. Of the 205 that completed or were terminated, 61 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
134 of 317 have an industry lead sponsor. The 10 most frequent:
French Cardiology Society is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
French Cardiology Society has 5 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
23 of the studies in Atrial Fibrillation with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT05773638University Hospital, BrestCardiovascular and Venous Thromboembolism Disease in Patients with Von Willebrand Disease in the French West | 2026-12-26 |
| NCT05777551Clinica MediterraneaAF Ablation With High Power Short Duration RF | 2026-12-31 |
| NCT05790707Poitiers University HospitalEfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment | 2027-01 |
| NCT07116525Biosense Webster, Inc.A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter | 2027-02-07 |
Among the 317 studies in Atrial Fibrillation with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to assess the clinical efficacy of physiological pacing combined with atrioventricular node ablation, in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and well controlled permanent atrial fibrillation.The main question it aims to answer is that heart rate regularization added to physiological pacing - preventing the deleterious effect of right ventricular apical pacing - would reduce mortality and heart failure hospitalizations.
Researchers will compare physiological pacing combined with atrioventricular node ablation (intervention arm) versus optimal pharmacological therapy (control arm) to see if physiological pacing combined with atrioventricular node ablation reduce time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics (time frame 24 months).
Participants will :
Heart failure with preserved ejection fraction is a major public health issue affecting 4.9% of general population aged ≥ 60 years. It accounts for more than half of all heart failure hospital admissions. Atrial fibrillation is very common in this diseased population as pathophysiologies are highly interrelated. Atrial fibrillation occurs in two thirds of Heart failure with preserved ejection patients at some point in the natural history and confers a poor prognosis. Therapeutic alternatives are currently limited as patients with permanent Atrial fibrillation and Heart failure with preserved ejection are often treated with drug therapies for lenient rate control.
Recently, the APAF-CRT mortality trial demonstrated a reduction in mortality and hospitalization in Heart Failure and Atrial fibrillation patients treated with Atrioventricular node ablation plus Cardiac Resynchronization Therapy versus pharmacological rate control, irrespective of their baseline Ejection Fraction. The optimal rate regularization achieved with atrioventricular node ablation emerges as the main determinant of reduction in mortality and hospitalization. This conclusion is supported by old robust physiology studies showing that beat-to-beat heart rate irregularity has significant hemodynamic effects and notably decreases cardiac output. However, no specific trials have been conducted in patients with Heart failure with preserved ejection, a population for whom treatment strategies that effectively improve outcomes are sparse. We aim at analyzing the benefit of heart rate regularization and physiological pacing in patients with Heart failure with preserved ejection (Left Ventricular Ejection Fraction ≥ 50%) and permanent Atrial Fibrilation.
We hypothesize that heart rate regularization added to physiological pacing - preventing the deleterious effect of right ventricular apical pacing - would reduce mortality and Heart Failure hospitalizations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of at least one of the following criteria related to diastolic dysfunction:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pacemaker implantation and atrioventricular node ablation will be performed within a one week period after the randomization.Pharmacological heart failure therapy will be optimized according to current guidelines.
Procedure: pacemaker implantation · Procedure: atrioventricular node ablation · Device: Pacemaker programming
Conventional care support. The rate control therapy will be optimized to achieve a resting heart rate of \<110 beats per minute. Pharmacological heart failure therapy will be optimized according to current guidelines.
The Medtronic 3830 lead should be used as the Conduction System Pacing lead. However, in case of unsuccessful implantation with the 3830 lead, a stylet-driven lead can be used as an alternative.
Right-sided atrioventricular junction ablation will be attempted first with a radiofrequency catheter. The choice of the catheter will be at the discretion of the physician. The catheter will be advanced to the His Bundle and then slightly withdrawn proximally and caudally in order to target the compact atrioventricular node. Repeated ablation procedures will be recommended during follow-up if regression of atrioventricular block occurs.
The pacemaker device will be programmed in VVIR mode at a lower rate of 75 beats per minute in bipolar mode for sensing and pacing
Time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics.
Delay between randomization and death or hospitalization or intravenous diuretics due to heart failure
Time frame: 24 months
Time to all-cause mortality
Delay between randomization and death (all-cause).
Time frame: 24 months
Time to Cardiovascular mortality
Delay between randomization and death due to cardiovascular disease.
Time frame: 24 months
Time to heart failure hospitalization
Delay between randomization and hospitalization due to heart failure.
Time frame: 24 months
Change in New York Heart Association score
Evolution of the functional status measured by New York Heart Association score between randomization and 24 months follow up visit. From II (mild), III (moderate) to IV (severe).
Time frame: 24 months
Change in B-type natriuretic peptide level
Evolution of B-type natriuretic peptide (BNP) level between randomization and 24 months follow up visit.
Time frame: 24 months
Major adverse events following pacemaker implantation
Record of safety information about pacemaker implantation procedure
Time frame: 24 months
Major adverse events following atrioventricular node ablation
Record of safety information about atrioventricular node ablation procedure
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2029, 44 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 44 months is close to that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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French Cardiology Society