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AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation (APAF-CSP)

19. května 2026 aktualizováno: M. Rienstra, University Medical Center Groningen

AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation: The APAF-CSP All-cause Mortality and Quality of Life Trial

The goal of this clinical trial is to learn if conduction system pacing works as well as cardiac resynchronization therapy (CRT) post atrioventricular (AV) node ablation in adult patients with symptomatic heart failure and atrial fibrillation that is not suitable for rhythm control.

The main question it aims to answer is:

Is AV node ablation with conduction system pacing noninferior to AV node ablation with CRT for the hierarchical composite outcome of all-cause mortality, heart failure hospitalization or urgent heart failure visit, and meaningful improvement in heart failure-related quality of life?

Participants will undergo:

  • An AV node ablation and be randomly assigned to receive either a conduction system pacing or a CRT.
  • Attend follow-up visits (in clinic or by telephone) at baseline, intervention day, 3-month, 12-month, 24-month, and 36-month after the procedure.
  • Complete questionnaires about heart failure symptoms and quality of life at baseline, 12 months, and yearly.
  • Have an echocardiogram, an electrocardiogram, and blood tests at baseline and 1 year
  • At selected centers: they will be asked to wear a bracelet that measures arterial stiffness for 30 minutes and provide a urine sample at baseline and 1 year.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

  • Study Rationale:

Therapeutic options for patients with symptomatic HF and AF that is not suitable for rhythm control are limited to pharmacological rate control and/or AV node ablation plus CRT implantation (Class IIa, Level of Evidence B). CSP is gaining more and more attention, and it has the advantage of utilizing the native conduction system to activate both ventricles simultaneously. This would achieve more physiologically synchronized ventricular contraction and circulation dynamics. We hypothesize that conduction system pacing would be as efficient as CRT pacing in patients with symptomatic heart failure and AF that is not suitable for rhythm control who are receiving the "ablate and pace" treatment strategy.

+Objective:

  1. Primary Objective:

    To compare AV node ablation with conduction system pacing versus AV node ablation with cardiac resynchronization therapy (CRT) among the trial population with respect to the hierarchical composite endpoint of all-cause mortality, HF hospitalization or unplanned/urgent HF visit, and ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.

  2. Secondary Objectives:

    To determine the effect of AV node ablation with conduction system pacing compared to AV node ablation with cardiac resynchronization therapy (CRT) among the trial population in the following outcomes:

    -≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.

    • Quality of life measures (EQ-5D and AFEQT questionnaires). -HF hospitalization or unplanned/urgent HF visit. -Cardiovascular related hospitalization. -All-cause mortality. -Cardiovascular related mortality. Tertiary (Exploratory) Objectives: To determine the effect of AV node ablation with conduction system pacing compared to AV node ablation with cardiac resynchronization therapy (CRT) among the trial population in the following outcomes:
    • Duration of hospitalization for cardiovascular causes
    • Worsening heart failure (NYHA class at baseline,1 year and at end of follow-up),
    • Healthcare costs and cost-effectiveness,
    • Trends of NT-proBNP levels at baseline and follow up
    • Change in left ventricular ejection fraction (LVEF) at baseline and 1 year
    • Change in renal function metrics (Glomerular Filtration Rate (GFR), Creatinine (Cr) and blood Urea levels (BUN)) at baseline and 1 year.
    • Change in urine Microalbumin (by urine dipstick) at baseline and 1 year (only in the subgroup analysis).
    • Change in measured arterial stiffness index measured by the photoplethysmography (PPG) signals through a non-invasive blood-volume sensing wearable bracelet, at baseline and 1 year (only in the subgroup analysis).
    • Short-term safety outcomes: This includes the composite of short-term (i.e. within 3 months) post procedure related complications (i.e. Cardiac tamponade, Pneumothorax, postoperative wound infection, Pocket hematomas, lead dislodgment, vascular injury, Thromboembolism, and Pericarditis).

    • Long term safety outcomes: This includes the composite of long-term (i.e. within 3 years) post procedure related complications (Device and Lead integrity related complications (i.e. lead dislodgment, lead malfunction, generator malfunction, lead related infections)).

      • Study design:

    The APAF-CSP trial is a prospective, multicenter, international, randomized, open-label, non-inferiority, parallel-arms trial. Patients who have atrial fibrillation (AF), that is not suitable for rhythm control, and a history of at least one hospitalization or unplanned/urgent care visit due to heart failure within the last 2 years, regardless of left ventricular ejection fraction or QRS duration, will be invited to participate. The trial will take place in 23 participating hospitals in Europe (Netherlands, Germany, Italy and France).

    +Study population: Adult patients aged 18 years or older, with confirmed AF that is unsuitable for rhythm control and symptomatic HF (with a history of at least one hospitalization or unplanned/urgent care visit due to HF exacerbation within the 2 years before enrolment), regardless of left ventricular ejection fraction or QRS duration, will be invited to participate in this trial. Based on sample size estimations, the trial needs 292 patients with a median follow-up of 2.5 years.

    +Intervention: All patients meeting the inclusion criteria and not meeting any exclusion criteria will be randomized in a 1:1 ratio to undergo either AV node ablation with CSP or AV node ablation with CRT implantation. Throughout the trial, patients will be followed up at predefined intervals for endpoint data collection.

    +Main study endpoint: The hierarchical primary composite endpoint is the composite of all-cause mortality, HF hospitalization or unplanned/urgent HF visit, and ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ).

    +Nature and extent of the burden and risks associated with participation, benefit and group relatedness: AV node catheter ablation and pacemaker implantation, whether CRT or CSP, are well-established and safe techniques. They are well-known for their efficiency for rate control in the appropriate population. The follow-up assessments will be conducted either physically (i.e. patient visits) and/or (when possible) remotely (i.e. telephone encounter) to minimize patient effort. Additional study procedures, such as transthoracic echocardiography and blood sample collection, will be performed at baseline during the screening assessment and during the 1-year follow-up visit. These procedures are part of usual clinical care for these patients undergoing AV nodal ablation with pacemaker implantation. Consequently, the additional effort and time to fill out a few "Quality-of-Life" questionnaires are determined to be the main extra burden that consumes time for both the patient and the treating physician. However, this increased burden is non-invasive and will be highlighted in the consent/participation form. In pre-selected centers (subgroup analyses), a urine sample for the microalbumin check will be collected at baseline and the 1-year visit. Furthermore, the vascular stiffness index (VSI) will be measured by a wearable bracelet. This VSI measurement will be performed at the baseline visit and at the 1-year follow up visit, where the participant will be asked to wear the device for 30 minutes (during the visit). The VSI recording and urine microalbumin check are painless, non-invasive and fully funded by the study. The patient will not be required to come for an extra visit to the study site for the sole reason of this recording or for the urine sample, and instead, this is incorporated into the scheduled study visits. However, the increased burden of providing a urine sample and wearing the bracelet during the visit is fully acknowledged and will be highlighted in the consent/participation forms.

Typ studie

Intervenční

Zápis (Odhadovaný)

292

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Michiel Rienstra, MD, PhD, MHA, Professor
  • Telefonní číslo: +31503611327
  • E-mail: m.rienstra@umcg.nl

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age 18 years or above.
  • Patient is diagnosed with AF and deemed not amenable to rhythm control. This diagnosis of AF will be demonstrated by at least one Electrocardiograph (ECG) showing AF that was performed within one year prior to enrollment.
  • Has history of stable heart failure (regardless left ventricular ejection fraction) and has a history of at least one HF related hospitalization or emergency room/urgent care visit within 2 years prior to enrollment, despite being on maximally tolerable guideline directed medical therapy.
  • Willing and capable to provide informed consent.

Exclusion Criteria:

  • NYHA functional class IV.
  • Severe concomitant non-cardiac disease.
  • Patient who require any cardiac surgical intervention.
  • Previously implanted pacing devices (pacemaker/ICD/CRT) with ≥40% pacing burden.

  • Any of the following within the 3 months prior to enrollment:

    • Myocardial infarction
    • Unstable angina
    • Percutaneous coronary intervention
    • Stroke or TIA
    • Significant bleeding
    • Pericarditis/effusions
  • Coronary artery bypass surgery/atriotomy within 6 months prior to enrolment.
  • Women who are pregnant or breastfeeding.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: CSP Group (Intervention Group)
AV node ablation plus Conduction System Pacing implantation. CSP is established pacing strategy evaluated in comparison with CRT.
Postup: Conduction System Pacing
The implantation of a pacing device with a pacing lead that aims to capture and pace the native conduction system.
Aktivní komparátor: CRT Group (Control Group)
AV node ablation plus cardiac resynchronization therapy implantation. CRT is established standard pacing strategy.
Postup: Cardiac resynchronization therapy
The implantation of a pacing device with a pacing leads that aims to capture and pace both ventricles in a synchronized fashion, to achieve the best possible hemodynamic parameters and synchrony.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The hierarchical composite endpoint of all-cause mortality, HF hospitalization or unplanned/urgent HF visit, and ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition).
From enrollment to the end of follow up (median follow-up of 2.5 years)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Major secondary endpoint: ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition).
From enrollment to the end of follow up (median follow-up of 2.5 years)
Quality of Life Improvement (AFEQT Questionnaire)
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
The AFEQT is a disease-specific questionnaire that focuses on assessing the impact of AF on a person's QoL. It covers several domains, including symptoms, daily activities, treatment concerns, and treatment satisfaction. The AFEQT provides scores for each domain as well as a total score, allowing for a comprehensive evaluation of the specific aspects affected by AF on an individual's QoL. Scale 0-100, higher scores indicate no limitation or disability.
From enrollment to the end of follow up (median follow-up of 2.5 years)
Quality of Life Improvement (EQ-5D-5L Questionnaire)
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
The EQ-5D-5L is a questionnaire used to assess health-related QoL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels indicating the level of problems experienced by the individual ( 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems). The EQ-5D-5L also generates a summary index score that represents overall health status based on societal preferences for different health states.
From enrollment to the end of follow up (median follow-up of 2.5 years)
HF Hospitalization or Unplanned/urgent HF Visit
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
From enrollment to the end of follow up (median follow-up of 2.5 years)
Cardiovascular Related Hospitalization
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
From enrollment to the end of follow up (median follow-up of 2.5 years)
All-cause Mortality
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
From enrollment to the end of follow up (median follow-up of 2.5 years)
Cardiovascular Related Mortality
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
From enrollment to the end of follow up (median follow-up of 2.5 years)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Duration of hospitalization for cardiovascular causes
Časové okno: From enrollment to the end of follow up (median follow-up of 2.5 years)
Tertiary (Exploratory) Endpoint
From enrollment to the end of follow up (median follow-up of 2.5 years)
Clinical heart failure status (New York Heart Association (NYHA) Functional Classification)
Časové okno: At baseline,1-year, and at end of follow-up (median of 2.5 years follow-up).

Tertiary (Exploratory) Endpoint.

NYHA Classification (scale I-IV):

Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.
At baseline,1-year, and at end of follow-up (median of 2.5 years follow-up).
Healthcare costs and cost-effectiveness parameters
Časové okno: At the end of follow up (Median of 2.5 years follow up)
Tertiary (Exploratory) Endpoint
At the end of follow up (Median of 2.5 years follow up)
NT-proBNP levels
Časové okno: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Left ventricular ejection fraction (LVEF)
Časové okno: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Glomerular Filtration Rate (GFR)
Časové okno: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Creatinine (Cr) level
Časové okno: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Blood Urea level (BUN)
Časové okno: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Urine Microalbumin levels (Only in the subgroup analysis in selected centers)
Časové okno: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Arterial stiffness index measured by the photoplethysmography (PPG) signals (Only in the subgroup analysis in selected centers).
Časové okno: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Short-term safety endpoints
Časové okno: Within 3 months post the procedure
Tertiary (Exploratory) Endpoints. These includes the short-term (i.e. within 3 months) post procedure related complications (i.e. Cardiac tamponade, Pneumothorax, postoperative wound infection, Pocket hematomas, lead dislodgment, vascular injury, Thromboembolism, and Pericarditis)
Within 3 months post the procedure
Long term safety endpoints
Časové okno: Within 3 years post the procedure
Tertiary (Exploratory) Endpoints. These includes the long-term (i.e. within 3 years) post procedure related complications (Device and Lead integrity related complications (i.e. lead dislodgment, lead malfunction, generator malfunction, lead related infections)).
Within 3 years post the procedure

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Medical Center Groningen

Vyšetřovatelé

  • Studijní židle: Michiel Rienstra, MD, PhD, MHA, Professor, University Medical Center Groningen, Groningen, The Netherlands
  • Vrchní vyšetřovatel: Yuri Blaauw, MD, PhD, University Medical Center Groningen

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. června 2030

Dokončení studie (Odhadovaný)

1. června 2030

Termíny zápisu do studia

První předloženo

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

19. května 2026

První zveřejněno (Aktuální)

22. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

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ANO

Typ podpůrných informací pro sdílení IPD

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

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