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

2026년 5월 19일 업데이트: 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.

연구 개요

상세 설명

  • 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.

연구 유형

중재적

등록 (추정된)

292

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Michiel Rienstra, MD, PhD, MHA, Professor
  • 전화번호: +31503611327
  • 이메일: m.rienstra@umcg.nl

연구 연락처 백업

연구 장소

    • Provincie Groningen
      • Groningen, Provincie Groningen, 네덜란드
        • University Medical Center Groningen
        • 수석 연구원:
          • Yuri Blaauw, MD, PhD
        • 연락하다:
          • Michiel Rienstra, MD, PhD, MHA, Professor
          • 전화번호: +31503611327
          • 이메일: m.rienstra@umcg.nl
      • Gelsenkirchen, 독일
      • Mainz, 독일
        • University Medical Center Mainz
        • 연락하다:
      • München, 독일
        • Klinikum rechts der Isar
        • 연락하다:
      • Paderborn, 독일
        • St. Vincenz-Krankenhaus GmbH
        • 연락하다:
      • Stade, 독일
      • Florence, 이탈리아
      • Lavagna, 이탈리아
        • Department of Cardiology, Ospedali del Tigullio
        • 연락하다:
      • Milan, 이탈리아
      • Milan, 이탈리아
        • Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca
        • 연락하다:
      • Nola, 이탈리아
      • Reggio Emilia, 이탈리아
        • Department of Cardiology, Ospedale S. Maria Nuova
        • 연락하다:
      • Roma, 이탈리아
      • Tricase, 이탈리아
        • Department of Cardiology, Ospedale Panico
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Major secondary endpoint: ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Duration of hospitalization for cardiovascular causes
기간: 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)
기간: 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
기간: 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
기간: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Left ventricular ejection fraction (LVEF)
기간: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Glomerular Filtration Rate (GFR)
기간: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Creatinine (Cr) level
기간: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Blood Urea level (BUN)
기간: 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)
기간: 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).
기간: At baseline and 1-year follow up.
Tertiary (Exploratory) Endpoint
At baseline and 1-year follow up.
Short-term safety endpoints
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Michiel Rienstra, MD, PhD, MHA, Professor, University Medical Center Groningen, Groningen, The Netherlands
  • 수석 연구원: Yuri Blaauw, MD, PhD, University Medical Center Groningen

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2030년 6월 1일

연구 완료 (추정된)

2030년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 19일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 19일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다