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Heart Failure With Preserved Ejection FractionHF-RELIEFNCT06833138

Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization Versus Medical Rate Control

A study testing pacemaker implantation, atrioventricular node ablation and Pacemaker programming in people with Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation, Persistent, run by French Cardiology Society at 17 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
pacemaker implantation, atrioventricular node ablation and Pacemaker programming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
17 sitesFrance
Study dates
10 Sep 2025to 31 Dec 2029
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 fibrilation > 6 months
  • Preserved Left Ventricular Ejection Fraction ≥ 50%
  • ≥ 1 heart failure hospitalization in the previous year
  • NYHA (New York Heart Association) score ≥ 2
  • Presence of at least one of the following criteria related to diastolic dysfunction:
  • E/e' ratio > 9
Show all 14Show fewer
  • Left Ventricular mass > 95 g/m2 (female) or > 115 g/m2 (male) with h/R ratio > 0.42
  • NT pro BNP (B-type Natriuretic Peptide) > 365 pg/mL or BNP (B-type Natriuretic Peptide) > 105 pg/mL
  • Narrow QRS ≤ 120 ms
  • Average heart rate ≤ 110/min on 24 hours Holter monitoring
  • Age over 18-year-old
  • Capacity to understand the nature of the study, legal ability and willingness to give informed consent
  • Patient covered by a social insurance
  • Effective contraception and a negative pregnancy test in women of a childbearing age

Who cannot join

  • Patient eligible for atrial fibrilation catheter ablation
  • Life expectancy < 12 months
  • Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2)
  • Severe respiratory disease (severe chronic obstructive pulmonary disease with Gold ≥ 3 and/or chronic oxygen therapy)
  • Class III obesity (Body Mass Index ≥ 40)
  • Confirmed or suspected infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
Show all 13Show fewer
  • Obstructive hypertrophic cardiomyopathy
  • Previous implanted devices (Pacemaker / Implantable Cardioverter-Defibrillator / Cardiac Resynchronization Therapy)
  • Other indication for pacemaker implantation
  • Indication for implantable cardioverter-defibrillator
  • Ambulatory ≤ 50% of time
  • Pregnant women
  • Breast-feeding women

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tessa BERGOT, MSc contact

+33144907033

tessa.bergot@sfcardio.fr

17 sites in 1 country

France17 sites, 17 recruiting

  • CHU de Besançon - Hôpital Jean Monjoz

    Besançon

    Marc BADOZ, MD

    Not yet recruiting

  • CHRU de Caen - Hôpital Côte de Nacre

    Caen, 14000

    Pierre OLLITRAULT, MD

    Recruiting

  • CHRU de Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170

    Arnaud BISSON, MD

    Recruiting

  • CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

    Clermont-Ferrand

    Pierre Antoine CATALAN, MD

    Not yet recruiting

  • CHU Grenoble Alpes

    Grenoble, 38043

    Pascal DEFAYE, MD

    Not yet recruiting

  • Groupe Hospitalier La Rochelle-Ré-Aunis

    La Rochelle, 17019

    Antoine MILHEM, MD

    Recruiting

  • CHU de Lille - Institut Cœur-Poumons

    Lille, 59000

    Christelle MARQUIE, MD

    Not yet recruiting

  • GHICL Allome - Hôpital St Philibert

    Lomme, 59462

    Guillaume VIART, MD

    Recruiting

  • Clinique Millenaire

    Montpellier, 34000

    Nicolas CLEMENTY, MD

    Recruiting

  • CHU de Nantes - Hôpital Nord Laennec

    Nantes, 44093

    Damien MINOIS, MD

    Not yet recruiting

  • Institut Montsouris

    Paris

    Frédéric SEBAG, MD

    Not yet recruiting

  • CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque

    Pessac, 33604

    Pierre BORDACHAR, MD

    Not yet recruiting

  • CHU de Poitiers - Centre Cardiovasculaire

    Poitiers, 86021

    Rodrigue GARCIA, MD

    Recruiting

  • CHU de Rennes - Hôpital Pontchallou

    Rennes

    Thomas MARC, MD

    Not yet recruiting

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, 76000

    Frédéric ANSELME, MD

    Recruiting

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var

    Charles MORGAT, MD

    Not yet recruiting

  • CHRU de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy

    Mathieu ECHIVARD, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Atrioventricular (AV) Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization vs. Medical Rate Control

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).

Read more

Participants will :

  • Be randomized in intervention arm or control arm.
  • Visit the clinic 3 months, 12 months and 24 months after the randomization for checkups and tests.
Read the detailed description

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.

Being tested
pacemaker implantation, atrioventricular node ablation, Pacemaker programming
Keywords
Heart failure, Cardiac Resynchronization Therapy, Conduction System Pacing
Medical subject headings
Atrial Fibrillation, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pacemaker implantationProcedure or surgery

    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.

  • atrioventricular node ablationProcedure or surgery

    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.

  • Pacemaker programmingDevice

    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

Study groups in NCT06833138
Study groupRoleWhat they receive
Intervention group with pacemaker implantation and atrioventricular node ablationExperimentalPacemaker 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.
Receives: Procedure: pacemaker implantation; Procedure: atrioventricular node ablation; Device: Pacemaker programming
ControlNo interventionConventional 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

Secondary outcomes (7)

  1. Time to all-cause mortality

    Delay between randomization and death (all-cause).

    Measured: 24 months

  2. Time to Cardiovascular mortality

    Delay between randomization and death due to cardiovascular disease.

    Measured: 24 months

  3. Time to heart failure hospitalization

    Delay between randomization and hospitalization due to heart failure.

    Measured: 24 months

  4. 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).

    Measured: 24 months

  5. Change in B-type natriuretic peptide level

    Evolution of B-type natriuretic peptide (BNP) level between randomization and 24 months follow up visit.

    Measured: 24 months

  6. Major adverse events following pacemaker implantation

    Record of safety information about pacemaker implantation procedure

    Measured: 24 months

  7. Major adverse events following atrioventricular node ablation

    Record of safety information about atrioventricular node ablation procedure

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start10 Sep 2025
  3. Primary completion31 May 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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
Randomization 1:1 Intervention arm: Conduction system pacing (pacemaker implantation) + atrioventricular node ablation Control arm: optimal pharmacological therapy
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06833138
Sponsor's protocol ID
2023-01
Acronym
HF-RELIEF
Status last verified
Sep 2026
First submitted
13 Feb 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing pacemaker implantation, atrioventricular node ablation and Pacemaker programming in people with Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation, Persistent, run by French Cardiology Society at 17 sites in France.

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 14 inclusion and 13 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. 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 Tessa BERGOT, MSc (+33144907033, tessa.bergot@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics. (time frame: 24 months). 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 NCT06833138.

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 11 Sep 2026.

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