AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation (APAF-CSP)
19 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
- 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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
292
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Michiel Rienstra, MD, PhD, MHA, Professor
- Номер телефона: +31503611327
- Электронная почта: m.rienstra@umcg.nl
Учебное резервное копирование контактов
- Имя: Ahmed S Yassin, MD
- Электронная почта: a.s.e.m.yassin@umcg.nl
Места учебы
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Gelsenkirchen, Германия
- Marienhospital Gelsenkirchen
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Контакт:
- Axel Kloppe, MD
- Номер телефона: +49 209 1723601
- Электронная почта: kardiologie@marienhospital.eu
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Mainz, Германия
- University Medical Center Mainz
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Контакт:
- Peter Seidel, MD
- Номер телефона: +49 1791957811
- Электронная почта: peseidel@uni-mainz.de
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München, Германия
- Klinikum rechts der Isar
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Контакт:
- Eimo Martens, MD
- Номер телефона: +49 1714124861
- Электронная почта: eimo.martens@mri.tum.de
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Paderborn, Германия
- St. Vincenz-Krankenhaus GmbH
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Контакт:
- Andreas Goette, MD
- Номер телефона: +49 5251861651
- Электронная почта: Andreas.Goette@vincenz.de
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Stade, Германия
- Klinik für Kardiologie und Intensivmedizin
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Контакт:
- Peter Lüdike, MD
- Номер телефона: +49 5413264662
- Электронная почта: peter.luedike@niels-stensen-kliniken.de
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Florence, Италия
- Azienda Ospedaliero-Universitaria Careggi
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Контакт:
- Paolo Pieragnoli, MD
- Электронная почта: pieragnolip@aou-careggi.toscana.it
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Lavagna, Италия
- Department of Cardiology, Ospedali del Tigullio
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Контакт:
- Paolo Donateo, MD
- Электронная почта: Paolo.donateo@gmail.com
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Milan, Италия
- Ospedale San Raffaele
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Контакт:
- Bisceglia Caterina, MD
- Электронная почта: bisceglia.caterina@hsr.it
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Milan, Италия
- Department of Cardiology, IRCCS Instituto Auxologico Italiano, Ospedale San Luca
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Контакт:
- Michele Brignole, MD, Professor
- Электронная почта: mbrignole@outlook.it
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Nola, Италия
- Ospedale Santa Maria della Pieta
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Контакт:
- Mario Volpicelli, MD
- Электронная почта: epvolpicelli@gmail.com
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Reggio Emilia, Италия
- Department of Cardiology, Ospedale S. Maria Nuova
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Контакт:
- Matteo Iori, MD
- Электронная почта: Matteo.Iori@ausl.re.it
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Roma, Италия
- Ospedale San Pietro Fatebenefratelli
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Контакт:
- Daniele Porcelli, MD
- Электронная почта: daniele.porcelli@hotmail.it
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Tricase, Италия
- Department of Cardiology, Ospedale Panico
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Контакт:
- Pietro Palmisano, MD
- Электронная почта: dr.palmisano@libero.it
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's-Hertogenbosch, Нидерланды
- Jeroen Bosch Ziekenhuis
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Контакт:
- Wouter Wieringa, MD
- Электронная почта: w.wieringa@jbz.nl
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Leeuwarden, Нидерланды
- FrisiusMC
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Контакт:
- Marnix Van Bemmel, MD
- Электронная почта: marnixvanbemmel@outlook.com
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Maastricht, Нидерланды
- Maastricht UMC
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Контакт:
- Twan Van Stipdonk, MD
- Электронная почта: twan.van.stipdonk@mumc.nl
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Nieuwegein, Нидерланды
- Antonius hospital
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Контакт:
- Vincent Van Dijk, MD
- Электронная почта: v.van.dijk@antoniusziekenhuis.nl
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Provincie Groningen
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Groningen, Provincie Groningen, Нидерланды
- University Medical Center Groningen
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Главный следователь:
- Yuri Blaauw, MD, PhD
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Контакт:
- Michiel Rienstra, MD, PhD, MHA, Professor
- Номер телефона: +31503611327
- Электронная почта: m.rienstra@umcg.nl
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Grenoble, Франция
- CHU de GRENOBLE
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Контакт:
- Pascal Defaye, MD
- Электронная почта: PDefaye@chu-grenoble.fr
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Marseille, Франция
- CHU La Timone
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Контакт:
- Jean-claude Deharo, MD
- Электронная почта: jean-claude.deharo@ap-hm.fr
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Paris, Франция
- Hôpital Europeén Georges Pompidou
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Контакт:
- Eloi Marijon, MD
- Электронная почта: eloi.marijon@aphp.fr
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Rouen, Франция
- CHU de Rouen
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Контакт:
- Frederic Anselme, MD
- Электронная почта: frederic.anselme@chu-rouen.fr
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Toulouse, Франция
- Clinique Pasteur Toulouse
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Контакт:
- Serge Boveda, MD
- Электронная почта: sboveda@clinique-pasteur.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: 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.
|
|
Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
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.
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Major secondary endpoint: ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Временное ограничение: 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)
Временное ограничение: 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.
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From enrollment to the end of follow up (median follow-up of 2.5 years)
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Quality of Life Improvement (EQ-5D-5L Questionnaire)
Временное ограничение: 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)
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HF Hospitalization or Unplanned/urgent HF Visit
Временное ограничение: From enrollment to the end of follow up (median follow-up of 2.5 years)
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From enrollment to the end of follow up (median follow-up of 2.5 years)
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Cardiovascular Related Hospitalization
Временное ограничение: From enrollment to the end of follow up (median follow-up of 2.5 years)
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From enrollment to the end of follow up (median follow-up of 2.5 years)
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All-cause Mortality
Временное ограничение: 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)
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|
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Cardiovascular Related Mortality
Временное ограничение: 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)
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Duration of hospitalization for cardiovascular causes
Временное ограничение: 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)
Временное ограничение: 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).
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Healthcare costs and cost-effectiveness parameters
Временное ограничение: 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)
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NT-proBNP levels
Временное ограничение: At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
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Left ventricular ejection fraction (LVEF)
Временное ограничение: At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
|
Glomerular Filtration Rate (GFR)
Временное ограничение: At baseline and 1-year follow up.
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Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
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Creatinine (Cr) level
Временное ограничение: At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
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Blood Urea level (BUN)
Временное ограничение: 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)
Временное ограничение: 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).
Временное ограничение: At baseline and 1-year follow up.
|
Tertiary (Exploratory) Endpoint
|
At baseline and 1-year follow up.
|
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Short-term safety endpoints
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Учебный стул: Michiel Rienstra, MD, PhD, MHA, Professor, University Medical Center Groningen, Groningen, The Netherlands
- Главный следователь: Yuri Blaauw, MD, PhD, University Medical Center Groningen
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Van Gelder IC, Groenveld HF, Crijns HJ, Tuininga YS, Tijssen JG, Alings AM, Hillege HL, Bergsma-Kadijk JA, Cornel JH, Kamp O, Tukkie R, Bosker HA, Van Veldhuisen DJ, Van den Berg MP; RACE II Investigators. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. doi: 10.1056/NEJMoa1001337. Epub 2010 Mar 15.
- Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.
- Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
- Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
- Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
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- Jaramillo AP, Jaramillo L, Briones Andriuoli RR, Revilla JC, Castells J, Ibrahimli S, Villacres JL, Garzon Mora N. The Effectiveness of Ablation Therapy for Atrial Fibrillation: A Systematic Review. Cureus. 2023 Aug 23;15(8):e43992. doi: 10.7759/cureus.43992. eCollection 2023 Aug.
- Sugumar H, Nanayakkara S, Chieng D, Wong GR, Parameswaran R, Anderson RD, Al-Kaisey A, Nalliah CJ, Azzopardi S, Prabhu S, Voskoboinik A, Lee G, McLellan AJ, Ling LH, Morton JB, Kalman JM, Kistler PM. Arrhythmia recurrence is more common in females undergoing multiple catheter ablation procedures for persistent atrial fibrillation: Time to close the gender gap. Heart Rhythm. 2020 May;17(5 Pt A):692-698. doi: 10.1016/j.hrthm.2019.12.013. Epub 2019 Dec 19.
- Is atrial fibrillation the "new epidemic" in heart health? Understanding that the condition is a permanent one is an important first step is adjusting life with this common arrhythmia. Heart Advis. 2011 Sep;14(9):5. No abstract available.
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 июля 2026 г.
Первичное завершение (Оцененный)
1 июня 2030 г.
Завершение исследования (Оцененный)
1 июня 2030 г.
Даты регистрации исследования
Первый отправленный
12 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
19 мая 2026 г.
Первый опубликованный (Действительный)
22 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
22 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
19 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- Сердечная недостаточность
- Мерцательная аритмия
- Качество жизни
- Фотоплетизмография
- Госпитализация по поводу сердечной недостаточности
- Эквалайзер-5D
- Опросник кардиомиопатии Канзас-Сити (KCCQ)
- Сердечная ресинхронизация
- Смертность от всех причин
- Стимуляция системы проводимости
- AV Nodal Ablation
- Unplanned/urgent HF visit
- Arterial Stiffness Index
- APAF-CSP
- AFEQT
Дополнительные соответствующие термины MeSH
- Сердечно-сосудистые заболевания
- Патологические процессы
- Сердечные заболевания
- Аритмии, Сердечные
- Патологические состояния, признаки и симптомы
- Сердечная недостаточность
- Мерцательная аритмия
- Терапия
- Электрическая стимуляционная терапия
- Искусственная электрокардиостимуляция
- Кардиальная ресинхронизирующая терапия
Другие идентификационные номера исследования
- NL-011147
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .