A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II)
评估除导管消融之外的肾动脉去神经术以消除心房颤动的试验 (ERADICATE-AF II)
基本信息
- 批准号:10685356
- 负责人:
- 金额:$ 23.68万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-09-01 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:AblationAdverse effectsAmbulatory Blood Pressure MonitoringAmbulatory MonitoringAnti-Arrhythmia AgentsArrhythmiaAtrial FibrillationAutonomic ganglionAutonomic nervous systemBlood PressureCardiacCardiac ablationCardiovascular systemCessation of lifeClinicalClinical TrialsComplicationCoupledDenervationDevelopmentEFRACEchocardiographyEmergency department visitEventFailureFrequenciesGoalsHospitalizationHourHypertensionImplantMeasurementMeasuresMediatingMedicalMuscleNerveNorepinephrineOutcomeOutputPatientsPharmaceutical PreparationsPosturePre-Clinical ModelProceduresPublishingPulmonary veinsQuality of lifeRandomizedRecurrenceResistanceResistant HypertensionSingle-Blind StudySympathetic Nervous SystemTechniquesTestingTherapeuticThickTimecardiovascular emergencyfollow-uphypertensivesindexingpilot trialpredict clinical outcomepressureprogramsrandomized trialrandomized, clinical trialsrenal arterysafety assessmentsuccesssymptomatic improvementtrial enrollment
项目摘要
ABSTRACT
Pulmonary vein isolation (PVI) is the cornerstone of ablation strategies for atrial fibrillation (AF) and has been
consistently effective in reducing arrhythmia recurrence. Nonetheless, PVI has a recognized and not insignificant
rate of short- and long-term failure, often requires multiple procedures and is less effective for persistent AF. The
mechanisms of AF are diverse, but increased efferent cardiac sympathetic nerve stimulation can contribute to the
development and perpetuation of AF. Reduction in cardiac sympathetic input has been proposed as a logical
adjunctive approach to PVI but its technical application via cardiac ablation has had only mixed or modest results.
The therapeutic objective of reduced cardiac sympathetic stimulation can be potentially accomplished by renal
artery denervation (RDN), a technique originally developed for the treatment of resistant hypertension. RDN’s
potential for antiarrhythmic effect may be mediated by reduced central nervous sympathetic output and is
exemplified by a decrease in whole-body norepinephrine spillover and muscle-sympathetic nerve activity.
The recently completed randomized, multicenter, single-blind clinical trial, ERADICATE-AF, was published in
JAMA and convincingly demonstrated that RDN plus PVI resulted in a relative 43% reduction (absolute change,
15%; P < 0.001) in recurrent incident AF during one year of follow-up. The trial enrolled > 300 patients with
paroxysmal AF referred for ablation, all with poorly controlled hypertension despite medication. There was no
difference in complications between the 2 groups. The trial results suggested that a strategy of reducing cardiac
autonomic input is an effective antiarrhythmic approach. Until now, this approach has only been tested in patients
with resistant and/or poorly controlled hypertension.
We propose a multicenter, single-blinded, randomized clinical trial to Evaluate Renal Artery Denervation In
Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II), to test the hypothesis that RDN
in addition to PVI enhances long-term antiarrhythmic efficacy in comparison to PVI alone for patients with
persistent AF with controlled hypertension or without hypertension. The trial will be advantaged by performing
implantable loop recordings (ILR) in all patients, which will facilitate the calculation of AF burden, now recognized
as a powerful predictor of clinical outcome. With successful completion of this pilot program, we hope to launch
a large-scale trial with cardiovascular and death events as endpoints.
The principal goal of this trial is to determine if adjunctive RDN results in reduced AF burden over time in
comparison to patients who undergo only PVI. The secondary goals are to examine: procedural complication,
postural blood pressure, and pressure control as assessed by 24-hour ambulatory monitors; autonomic nervous
system effects; frequency of cardiovascular hospitalizations; return to persistent AF; need for repeat ablation
procedures; and quality of life.
摘要
肺静脉隔离(PVI)是房颤(AF)消融策略的基石,
持续有效地减少心律失常复发。尽管如此,PVI具有公认的且并非微不足道的
短期和长期失败率,通常需要多次手术,对持续性AF效果较差。
AF的机制是多种多样的,但是增加的传出心脏交感神经刺激可以有助于AF的发生。
心脏交感神经输入的减少已被提出作为一个逻辑的
肺静脉隔离的成功方法,但其通过心脏消融术的技术应用只有混合或适度的结果。
减少心脏交感神经刺激的治疗目标可以通过肾移植潜在地实现。
动脉去神经支配(RDN),一种最初为治疗顽固性高血压而开发的技术。RDN's
潜在的抗癫痫作用可能是通过减少中枢神经交感神经输出来介导的,
例如全身去甲肾上腺素溢出和肌肉交感神经活动的减少。
最近完成的随机、多中心、单盲临床试验ERADICATE-AF发表在
JAMA和令人信服地证明,RDN加PVI导致相对43%的减少(绝对变化,
15%; P < 0.001)。该试验招募了> 300名患者,
阵发性房颤转介消融,尽管使用药物,但高血压控制不佳。没有
两组之间的并发症差异。试验结果表明,减少心脏病的策略
自主神经输入是一种有效的抗抑郁方法。到目前为止,这种方法只在患者身上进行过测试
患有顽固性和/或控制不佳的高血压。
我们提出了一个多中心,单盲,随机临床试验,以评估肾动脉去神经,
增加导管消融消除房颤(ERADICATE-AF II),以检验RDN
与单纯肺静脉隔离相比,肺静脉隔离还可增强患者的长期抗肿瘤疗效,
持续性房颤伴控制性高血压或不伴高血压。试验将通过表演
所有患者的植入式线圈记录(ILR),这将有助于计算AF负担,现在已被认可
作为临床结果的有力预测器。随着这项试点计划的成功完成,我们希望推出
一项以心血管和死亡事件为终点的大规模试验。
本试验的主要目的是确定连续性RDN是否会随着时间的推移减少AF负担,
与仅接受肺静脉隔离的患者相比。次要目标是检查:手术并发症,
通过24小时动态监测仪评估体位血压和压力控制;自主神经
系统效应;心血管住院频率;复发持续性AF;需要重复消融
程序;和生活质量。
项目成果
期刊论文数量(2)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Ready to deploy prophylactics?
准备好部署预防措施了吗?
- DOI:10.1111/jce.15482
- 发表时间:2022
- 期刊:
- 影响因子:2.7
- 作者:Aktas,MehmetK;Steinberg,JonathanS
- 通讯作者:Steinberg,JonathanS
The Emerging Therapeutic Potential of Botulinum Toxin in Cardiology.
- DOI:10.1016/j.hrthm.2022.08.032
- 发表时间:2022-09
- 期刊:
- 影响因子:5.5
- 作者:J. Steinberg;Alexander Romanov
- 通讯作者:J. Steinberg;Alexander Romanov
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Jonathan S. Steinberg其他文献
Continuous monitoring of atrial fibrillation in heart failure.
持续监测心力衰竭中的房颤。
- DOI:
10.1016/j.hfc.2013.06.002 - 发表时间:
2013 - 期刊:
- 影响因子:3.4
- 作者:
B. Herweg;S. Barold;Jonathan S. Steinberg - 通讯作者:
Jonathan S. Steinberg
PO-01-167 strongEFFICACY OF BOTULINUM TOXIN TYPE A (AGN-151607) FOR THE PREVENTION OF POSTOPERATIVE ATRIAL FIBRILLATION IN CARDIAC SURGERY PATIENTS: ATRIAL FIBRILLATION AND ANTICOAGULATION RESULTS FROM THE PHASE 2 NOVA STUDY/strong
PO-01-167 肉毒杆菌毒素 A 型(AGN-151607)预防心脏手术患者术后心房颤动的强效疗效:来自 2 期 NOVA 研究的心房颤动和抗凝结果/强
- DOI:
10.1016/j.hrthm.2023.03.558 - 发表时间:
2023-05-01 - 期刊:
- 影响因子:5.700
- 作者:
Nathan Waldron;Alexandra OSullivan;Jonathan P. Piccini;Matthew Romano;Pierre Voisine;Wilson Titanji;Richard Leaback;William Ferguson;Jonathan S. Steinberg - 通讯作者:
Jonathan S. Steinberg
Role of Atrioventricular Junctional Ablation and Cardiac Resynchronization Therapy in Patients with Chronic Atrial Fibrillation
- DOI:
10.1016/j.ccep.2018.11.013 - 发表时间:
2019-03-01 - 期刊:
- 影响因子:
- 作者:
Jonathan S. Steinberg - 通讯作者:
Jonathan S. Steinberg
The Influence of Bundle Branch Morphology on Outcomes with Cardiac Resynchronization in NYHA Class III/IV Heart Failure: Insights from the COMPANION Study
- DOI:
10.1016/j.cardfail.2010.06.221 - 发表时间:
2010-08-01 - 期刊:
- 影响因子:
- 作者:
Leslie A. Saxon;Jonathan S. Steinberg;Patrick Yong;Elizabeth Galle;John Boehmer - 通讯作者:
John Boehmer
Safety and efficacy of flestolol, a new ultrashort-acting beta-adrenergic blocking agent, for supraventricular tachyarrhythmias
- DOI:
10.1016/s0002-9149(86)80028-5 - 发表时间:
1986-11-01 - 期刊:
- 影响因子:
- 作者:
Jonathan S. Steinberg;Richard J. Katz;John C. Somberg;Deborah Keefe;Atul R. Laddu;Judy Burge - 通讯作者:
Judy Burge
Jonathan S. Steinberg的其他文献
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{{ truncateString('Jonathan S. Steinberg', 18)}}的其他基金
A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II)
评估除导管消融之外的肾动脉去神经术以消除心房颤动的试验 (ERADICATE-AF II)
- 批准号:
10470105 - 财政年份:2021
- 资助金额:
$ 23.68万 - 项目类别:
A Trial to Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF II)
评估除导管消融之外的肾动脉去神经术以消除心房颤动的试验 (ERADICATE-AF II)
- 批准号:
10212737 - 财政年份:2021
- 资助金额:
$ 23.68万 - 项目类别:
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