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Compares treatment options for Heart Failure With Preserved Ejection Fraction
Official title 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
ClinicalTrials.gov ID: NCT06833138
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Leuven, Belgium
- Ottignies-Louvain-la-Neuve, Belgium
- Brest, France
- Caen, France
- Chambray-lès-Tours, France
- Grenoble, France
- La Rochelle, France
- Lille, France
- Lomme, France
- Montpellier, France
- Nantes, France
- Pessac, France
- Poitiers, France
- Rouen, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Leuven, Belgium; Ottignies-Louvain-la-Neuve, Belgium; Brest, France; Caen, France; Chambray-lès-Tours, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.