Atrioventricular node ablation with conduction system pacing versus drug rate control for HFpEF patients with permanent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with well-controlled permanent atrial fibrillation and heart failure with preserved ejection fraction are randomized to receive either atrioventricular node ablation plus physiological (conduction system) pacing or optimal pharmacological rate control. The trial compares time to a composite endpoint of all-cause mortality, hospitalization for heart failure, or need for intravenous diuretics over a 24-month follow-up. Participants attend clinic visits at baseline and at roughly 3, 12, and 24 months for device checks and outcome assessment. The study targets patients with prior heart-failure hospitalization, preserved LVEF, narrow QRS, and average heart rate ≤110/min on 24-hour Holter monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
  * 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

Exclusion Criteria:

* 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)
* 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

Where it's running

• CHRU de Caen - Hôpital Côte de Nacre
  Caen, France Recruiting
• CHRU de Tours - Hôpital Trousseau
  Chambray-lès-Tours, France Recruiting
• Groupe Hospitalier La Rochelle-Ré-Aunis
  La Rochelle, France Recruiting
• GHICL Allome - Hôpital St Philibert
  Lomme, France Recruiting
• Clinique Millenaire
  Montpellier, France Recruiting
• CHU de Poitiers - Centre Cardiovasculaire
  Poitiers, France Recruiting

Study contacts

• Principal investigator: Frédéric ANSELME, MD — CHU de Rouen, France
• Study coordinator: Tessa BERGOT, MSc
• Email: tessa.bergot@sfcardio.fr
• Phone: +33144907033

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote rehabilitation for HFpEF patients using telerehabilitation

  A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.

  Recruiting at 3 sites American Heart of Poland · Chrzanów and 2 other locations · NCT07918209

• EDG-15400 in adults with HFpEF: a phase 2 study

  This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 2 Edgewise Therapeutics, Inc. · Birmingham, Alabama and 27 other locations · NCT07795814

• Incretin therapy with tirzepatide for obesity-related HFpEF

  A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07554638

• Boosted exercise with group coaching for HFpEF

  This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07413198

• Exercise cardiac MRI for heart failure with preserved ejection fraction

  This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07401771

• HRS-1893 for heart failure with preserved ejection fraction

  This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.

  Recruiting Phase 2 Shandong Suncadia Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT07269717

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.