AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation (APAF-CSP)
2026年5月19日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
- 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:
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.
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.
研究の種類
介入
入学 (推定)
292
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Michiel Rienstra, MD, PhD, MHA, Professor
- 電話番号：+31503611327
- メール：m.rienstra@umcg.nl
研究連絡先のバックアップ
- 名前：Ahmed S Yassin, MD
- メール：a.s.e.m.yassin@umcg.nl
研究場所
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Florence、イタリア
- Azienda Ospedaliero-Universitaria Careggi
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コンタクト：
- Paolo Pieragnoli, MD
- メール：pieragnolip@aou-careggi.toscana.it
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Lavagna、イタリア
- Department of Cardiology, Ospedali del Tigullio
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コンタクト：
- Paolo Donateo, MD
- メール：Paolo.donateo@gmail.com
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Milan、イタリア
- Ospedale San Raffaele
-
コンタクト：
- Bisceglia Caterina, MD
- メール：bisceglia.caterina@hsr.it
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Milan、イタリア
- Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca
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コンタクト：
- Michele Brignole, MD, Professor
- メール：mbrignole@outlook.it
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Nola、イタリア
- Ospedale Santa Maria della Pieta
-
コンタクト：
- Mario Volpicelli, MD
- メール：epvolpicelli@gmail.com
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Reggio Emilia、イタリア
- Department of Cardiology, Ospedale S. Maria Nuova
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コンタクト：
- Matteo Iori, MD
- メール：Matteo.Iori@ausl.re.it
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Roma、イタリア
- Ospedale San Pietro Fatebenefratelli
-
コンタクト：
- Daniele Porcelli, MD
- メール：daniele.porcelli@hotmail.it
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Tricase、イタリア
- Department of Cardiology, Ospedale Panico
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コンタクト：
- Pietro Palmisano, MD
- メール：dr.palmisano@libero.it
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's-Hertogenbosch、オランダ
- Jeroen Bosch Ziekenhuis
-
コンタクト：
- Wouter Wieringa, MD
- メール：w.wieringa@jbz.nl
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Leeuwarden、オランダ
- FrisiusMC
-
コンタクト：
- Marnix Van Bemmel, MD
- メール：marnixvanbemmel@outlook.com
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Maastricht、オランダ
- Maastricht UMC
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コンタクト：
- Twan Van Stipdonk, MD
- メール：twan.van.stipdonk@mumc.nl
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Nieuwegein、オランダ
- Antonius hospital
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コンタクト：
- Vincent Van Dijk, MD
- メール：v.van.dijk@antoniusziekenhuis.nl
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Provincie Groningen
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Groningen、Provincie Groningen、オランダ
- University Medical Center Groningen
-
主任研究者：
- Yuri Blaauw, MD, PhD
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コンタクト：
- Michiel Rienstra, MD, PhD, MHA, Professor
- 電話番号：+31503611327
- メール：m.rienstra@umcg.nl
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Gelsenkirchen、ドイツ
- Marienhospital Gelsenkirchen
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コンタクト：
- Axel Kloppe, MD
- 電話番号：+49 209 1723601
- メール：kardiologie@marienhospital.eu
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Mainz、ドイツ
- University Medical Center Mainz
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コンタクト：
- Peter Seidel, MD
- 電話番号：+49 1791957811
- メール：peseidel@uni-mainz.de
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München、ドイツ
- Klinikum rechts der Isar
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コンタクト：
- Eimo Martens, MD
- 電話番号：+49 1714124861
- メール：eimo.martens@mri.tum.de
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Paderborn、ドイツ
- St. Vincenz-Krankenhaus GmbH
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コンタクト：
- Andreas Goette, MD
- 電話番号：+49 5251861651
- メール：Andreas.Goette@vincenz.de
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Stade、ドイツ
- Klinik für Kardiologie und Intensivmedizin
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コンタクト：
- Peter Lüdike, MD
- 電話番号：+49 5413264662
- メール：peter.luedike@niels-stensen-kliniken.de
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Grenoble、フランス
- CHU de GRENOBLE
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コンタクト：
- Pascal Defaye, MD
- メール：PDefaye@chu-grenoble.fr
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Marseille、フランス
- CHU La Timone
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コンタクト：
- Jean-claude Deharo, MD
- メール：jean-claude.deharo@ap-hm.fr
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Paris、フランス
- Hôpital Europeén Georges Pompidou
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コンタクト：
- Eloi Marijon, MD
- メール：eloi.marijon@aphp.fr
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Rouen、フランス
- CHU de Rouen
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コンタクト：
- Frederic Anselme, MD
- メール：frederic.anselme@chu-rouen.fr
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Toulouse、フランス
- Clinique Pasteur Toulouse
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コンタクト：
- Serge Boveda, MD
- メール：sboveda@clinique-pasteur.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：CSP Group (Intervention Group)
AV node ablation plus Conduction System Pacing implantation.
CSP is established pacing strategy evaluated in comparison with CRT.
|
The implantation of a pacing device with a pacing lead that aims to capture and pace the native conduction system.
|
|
アクティブコンパレータ：CRT Group (Control Group)
AV node ablation plus cardiac resynchronization therapy implantation.
CRT is established standard pacing strategy.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Major secondary endpoint: ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration of hospitalization for cardiovascular causes
時間枠：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)
時間枠：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
時間枠：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
時間枠：At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
|
Left ventricular ejection fraction (LVEF)
時間枠：At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
|
Glomerular Filtration Rate (GFR)
時間枠：At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
|
Creatinine (Cr) level
時間枠：At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
|
Blood Urea level (BUN)
時間枠：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)
時間枠：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).
時間枠：At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
|
Short-term safety endpoints
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Michiel Rienstra, MD, PhD, MHA, Professor、University Medical Center Groningen, Groningen, The Netherlands
- 主任研究者：Yuri Blaauw, MD, PhD、University Medical Center Groningen
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Clinical and Scientific Affairs Council; AAPA. Atrial fibrillation: more help for the most common arrhythmia. JAAPA. 2007 May;20(5):18, 21. No abstract available.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2030年6月1日
研究の完了 (推定)
2030年6月1日
試験登録日
最初に提出
2026年5月12日
QC基準を満たした最初の提出物
2026年5月19日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月22日
QC基準を満たした最後の更新が送信されました
2026年5月19日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- NL-011147
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。